To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT01068860
Collaborator
(none)
246
52
10
5.9
4.7
0.8
Study Details
Study Description
Brief Summary
This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
246 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Aug 1, 2010
Actual Study Completion Date
:
Aug 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Canakinumab 150 mg + Metformin Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening |
Drug: Canakinumab 150 mg
Single subcutaneous injection of Canakinumab 150 mg.
Other Names:
|
| Placebo Comparator: Placebo + Metformin Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening |
Drug: Placebo to Canakinumab
Single subcutaneous injection of Placebo to Canakinumab.
Other Names:
|
| Experimental: Canakinumab 150 mg + Metforimin + Sulfonylurea Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. |
Drug: Canakinumab 150 mg
Single subcutaneous injection of Canakinumab 150 mg.
Other Names:
|
| Placebo Comparator: Placebo + Metforimin + Sulfonylurea Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. |
Drug: Placebo to Canakinumab
Single subcutaneous injection of Placebo to Canakinumab.
Other Names:
|
| Experimental: Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. |
Drug: Canakinumab 150 mg
Single subcutaneous injection of Canakinumab 150 mg.
Other Names:
|
| Placebo Comparator: Placebo + Met + Sulfonyl + Thiazolidinedione Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. |
Drug: Placebo to Canakinumab
Single subcutaneous injection of Placebo to Canakinumab.
Other Names:
|
| Experimental: Canakinumab 150 mg + Insulin Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening |
Drug: Canakinumab 150 mg
Single subcutaneous injection of Canakinumab 150 mg.
Other Names:
|
| Placebo Comparator: Placebo + Insulin Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening |
Drug: Placebo to Canakinumab
Single subcutaneous injection of Placebo to Canakinumab.
Other Names:
|
| Experimental: Canakinumab 150 mg in patients with IGT Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
Drug: Canakinumab 150 mg
Single subcutaneous injection of Canakinumab 150 mg.
Other Names:
|
| Placebo Comparator: Placebo in patients with IGT Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
Drug: Placebo to Canakinumab
Single subcutaneous injection of Placebo to Canakinumab.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. [Baseline, 4 weeks]
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population
Secondary Outcome Measures
- Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
- Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks. [Baseline, 4 weeks]
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
- Mean Change in Fructosamine, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
- Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
- Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks [Baseline, 4 weeks]
The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks [Baseline, 4 weeks]
GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.
- Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks [Baseline, 4 weeks]
Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
- Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks [Baseline, 4 weeks]
Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
- Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks [Baseline, 4 weeks]
Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
- Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks [Baseline, 4 weeks]
Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
- Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks [Baseline, 4 weeks]
An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patient must fulfill all criteria in one of the following groups:
-
Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
-
Diagnosis of Type 2 diabetes in stable treatment with metformin
-
Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
-
Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
-
Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
-
HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
-
Age from 18-74 years, inclusive, and of either sex
Exclusion Criteria:
-
Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
-
History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
-
Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Research Institute | Los Angeles | California | United States | |
| 2 | Crest Clinical Trials | Santa Ana | California | United States | |
| 3 | Encompass Clinical Research | Spring Valley | California | United States | |
| 4 | Commonwealth Biomedical Research LLC | Madisonville | Kentucky | United States | |
| 5 | University of Nebraska Medical Center | Omaha | Nebraska | United States | |
| 6 | VA Medical Center | Omaha | Nebraska | United States | |
| 7 | Lillestol Research LLC | Fargo | North Dakota | United States | |
| 8 | Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | United States | |
| 9 | Dallas Diabetes and Endocrine Center | Dallas | Texas | United States | |
| 10 | Texas Center for Drug Development P.A. | Houston | Texas | United States | |
| 11 | Utah Clinical Trials | Salt Lake City | Utah | United States | |
| 12 | Barwon Health - Geelong Hospital | Geelong | Victoria | Australia | |
| 13 | Austin Health - Heidelberg Repatriation Hospital | Heidelberg Heights | Victoria | Australia | |
| 14 | Melbourne Health - Royal Melbourne Hospital | Melbourne | Victoria | Australia | |
| 15 | Lifestyle Metabolism Centre (Etobicoke) | Etobicoke | Ontario | Canada | |
| 16 | LMC Endocrinology Centres (Markham) Ltd | Markham | Ontario | Canada | |
| 17 | LMC Endocrinology Centres (Thornhill) Ltd | Thornhill | Ontario | Canada | |
| 18 | Centre de recherche clinique de Laval | Laval | Quebec | Canada | |
| 19 | Hôpital Maisonneuve-Rosemont | Montreal | Quebec | Canada | |
| 20 | Lihavuustutkimusyksikkö | Helsinki | Finland | ||
| 21 | Lääkärikeskus Mehiläinen Töölö | Helsinki | Finland | ||
| 22 | ODL Terveys Oy | Oulu | Finland | ||
| 23 | Clintrial Berlin Praxis fuer medizinische Studien | Berlin | Germany | ||
| 24 | Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov | Berlin | Germany | ||
| 25 | "Sana Krankenhaus Gerresheim | Duesseldorf | Germany | ||
| 26 | Gemeinschaftspraxis Dr. Ingo Zeissig | Duisburg | Germany | ||
| 27 | Praxis Dr. Thorsten Rau | Essen | Germany | ||
| 28 | Praxis Dr. med. Joerg Luedemann | Falkensee | Germany | ||
| 29 | Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok | Hildesheim | Germany | ||
| 30 | Praxis Dr. Julia Chevts | Karlsruhe | Germany | ||
| 31 | Pro Scientia Med | Luebeck | Germany | ||
| 32 | Praxis Dr. Winfried Keuthage | Muenster | Germany | ||
| 33 | Praxis Dr. Uwe Boeckmann | Neumuenster | Germany | ||
| 34 | Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G. | Potsdam | Germany | ||
| 35 | Praxis Dr. Gerhard Steinmaier | Viernheim | Germany | ||
| 36 | Praxis Dr. Reinhold U. Schneider | Wetzlar-Naunheim | Germany | ||
| 37 | Visakha Diabetes & Endocrine Centre | Visakhapatnam | AP | India | |
| 38 | Jnana Sanjeevini Medical Center | Bangalore | Kar | India | |
| 39 | Bangalore Diabetes Hospital, | Banglore | KAR | India | |
| 40 | Health & Research Centre | Trivandrum | Ker | India | |
| 41 | Indrayani Speciality Hospital, | Nagpur | Maharastra | India | |
| 42 | Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics | Pune | Mah | India | |
| 43 | Diabetes Thyroid Hormone Research Institute Pvt .Ltd. | Indore | MP | India | |
| 44 | Madras Diabetes Research Foundation | Chennai | TN | India | |
| 45 | Azienda Ospedaliera-Ospedali Riuniti di BergamoU | Bergamo | BG | Italy | |
| 46 | Az. Ospedaliera Universit. S.Martino-Universita degli Studi | Genova | GE | Italy | |
| 47 | Azienda Ospedaliera S. Paolo-Polo Universitario | Milano | MI | Italy | |
| 48 | Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità | Milano | Mi | Italy | |
| 49 | Az. Ospedaliera Della Prov.di Pavia | Casorate Primo | PV | Italy | |
| 50 | A.O.Universitaria Senese, Universita degli Studi di Siena | Siena | SI | Italy | |
| 51 | S.C.D.U. Endocrinologia e Malattie del Metabolismo | Torino | To | Italy | |
| 52 | Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore | Roma | Italy |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01068860
Other Study ID Numbers:
- CACZ885I2207
First Posted:
Feb 15, 2010
Last Update Posted:
Sep 5, 2011
Last Verified:
Aug 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Qualified patients entered a 4-week run-in period while taking current therapy thru the study. After the run-in, patients had the baseline meal challenge. Then patients were randomized. A 2nd meal challenge was performed after 4 wks. This ended the study except for a follow up phone call after approx.90 days to record serious adverse events (SAEs) |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Period Title: Overall Study | ||||||||||
| STARTED | 33 | 17 | 33 | 17 | 32 | 16 | 28 | 15 | 28 | 27 |
| COMPLETED | 33 | 16 | 33 | 16 | 32 | 14 | 28 | 15 | 28 | 23 |
| NOT COMPLETED | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 4 |
Baseline Characteristics
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Total of all reporting groups |
| Overall Participants | 33 | 17 | 33 | 17 | 32 | 16 | 28 | 15 | 28 | 27 | 246 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [years] |
55.9
(10.50)
|
56.5
(9.30)
|
60.0
(8.17)
|
59.4
(8.02)
|
59.1
(10.63)
|
57.2
(9.39)
|
58.6
(10.11)
|
57.0
(13.86)
|
52.8
(10.90)
|
57.6
(10.07)
|
57.4
(10.16)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
19
57.6%
|
3
17.6%
|
14
42.4%
|
10
58.8%
|
11
34.4%
|
5
31.3%
|
13
46.4%
|
10
66.7%
|
12
42.9%
|
16
59.3%
|
113
45.9%
|
| Male |
14
42.4%
|
14
82.4%
|
19
57.6%
|
7
41.2%
|
21
65.6%
|
11
68.8%
|
15
53.6%
|
5
33.3%
|
16
57.1%
|
11
40.7%
|
133
54.1%
|
Outcome Measures
| Title | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. |
|---|---|
| Description | Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [pmol/min/m^2/mmol/L] |
-0.06
(0.943)
|
-0.23
(1.334)
|
0.04
(0.958)
|
0.45
(1.378)
|
-0.79
(0.958)
|
1.16
(1.426)
|
1.23
(1.046)
|
-0.49
(1.378)
|
-1.50
(1.975)
|
-1.93
(1.737)
|
| Title | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks |
|---|---|
| Description | Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 30 | 15 | 31 | 14 | 26 | 15 | 28 | 20 |
| Least Squares Mean (Standard Error) [pmol/min/m^2/mmol/L] |
0.21
(2.000)
|
-2.15
(2.829)
|
-2.98
(2.066)
|
2.02
(2.921)
|
0.15
(2.032)
|
1.19
(3.024)
|
-0.43
(2.219)
|
-0.51
(2.921)
|
-0.71
(1.040)
|
-1.00
(1.518)
|
| Title | Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks. |
|---|---|
| Description | Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 16 | 31 | 15 | 32 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [pmol/min/m^2/mmol/L] |
0.44
(0.858)
|
-0.99
(1.232)
|
-0.32
(0.885)
|
1.22
(1.272)
|
-0.63
(0.871)
|
1.24
(1.317)
|
0.53
(0.966)
|
-0.49
(1.272)
|
-1.38
(1.356)
|
-1.35
(1.330)
|
| Title | Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks |
|---|---|
| Description | Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 16 | 31 | 16 | 32 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [mmol/L] |
-0.32
(0.272)
|
0.33
(0.391)
|
-0.20
(0.281)
|
-0.23
(0.391)
|
-0.33
(0.276)
|
-0.36
(0.418)
|
-0.26
(0.307)
|
-0.80
(0.404)
|
-0.06
(0.107)
|
0.10
(0.094)
|
| Title | Mean Change in Fructosamine, From Baseline to 4 Weeks |
|---|---|
| Description | Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 16 | 31 | 16 | 32 | 14 | 27 | 15 | 28 | 23 |
| Least Squares Mean (Standard Error) [mmol/L] |
-5.30
(3.727)
|
-0.75
(5.353)
|
-3.45
(3.846)
|
-7.50
(5.353)
|
-1.81
(3.785)
|
-3.07
(5.722)
|
-3.00
(4.121)
|
-19.73
(5.528)
|
-6.36
(3.259)
|
1.39
(3813)
|
| Title | Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks |
|---|---|
| Description | Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 15 | 30 | 15 | 31 | 13 | 26 | 15 | 28 | 23 |
| Least Squares Mean (Standard Error) [pmol/L] |
-3.58
(8.703)
|
10.73
(12.908)
|
-16.07
(9.128)
|
-9.40
(12.908)
|
-0.77
(8.979)
|
2.31
(13.866)
|
21.27
(9.805)
|
25.67
(12.908)
|
-.021
(6.093)
|
-3.43
(4.554)
|
| Title | Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks |
|---|---|
| Description | The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 15 | 30 | 15 | 31 | 13 | 25 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [number] |
0.004
(0.0080)
|
-0.000
(0.0119)
|
0.002
(0.0084)
|
0.009
(0.0119)
|
0.018
(0.0083)
|
-0.001
(0.0128)
|
-0.003
(0.0092)
|
0.005
(0.0119)
|
-0.001
(0.0051)
|
0.001
(0.0034)
|
| Title | Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks |
|---|---|
| Description | GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 15 | 30 | 15 | 30 | 13 | 25 | 15 | 26 | 21 |
| Index 1 |
0.06
(0.374)
|
-0.29
(0.546)
|
0.06
(0.386)
|
0.37
(0.546)
|
0.24
(0.386)
|
0.33
(0.586)
|
0.25
(0.423)
|
-0.27
(0.546)
|
-0.51
(0.672)
|
-0.64
(0.530)
|
| Index 2 (n= 32,15, 29,15, 30,13, 25, 15, 20, 26) |
0.14
(0.652)
|
-0.81
(0.952)
|
-0.94
(0.685)
|
0.81
(0.952)
|
0.62
(0.673)
|
0.49
(1.023)
|
-0.21
(0.738)
|
-0.25
(0.952)
|
-0.16
(0.396)
|
-0.31
(0.509)
|
| Title | Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks |
|---|---|
| Description | Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [mmol/L] |
-0.53
(0.389)
|
0.13
(0.551)
|
-0.60
(0.396)
|
0.18
(0.551)
|
-1.08
(0.396)
|
-0.56
(0.589)
|
-0.56
(0.432)
|
-0.16
(0.569)
|
-0.26
(0.241)
|
-0.25
(0.213)
|
| Title | Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks |
|---|---|
| Description | Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [pmol*hour/L] |
-9.37
(40.538)
|
1.21
(60.128)
|
-73.25
(42.517)
|
-38.32
(60.128)
|
-36.96
(41.825)
|
8.46
(64.587)
|
163.87
(45.670)
|
139.24
(60.128)
|
44.27
(60.700)
|
-106.68
(53.615)
|
| Title | Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks |
|---|---|
| Description | Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [nmol*hour/L] |
-0.18
(0.225)
|
-0.18
(0.324)
|
-0.21
(0.232)
|
0.12
(0.334)
|
-0.61
(0.229)
|
0.02
(0.346)
|
0.16
(0.249)
|
-0.29
(0.334)
|
-0.43
(0.253)
|
-0.40
(0.288)
|
| Title | Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks |
|---|---|
| Description | Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [mmol*hr/L] |
-0.59
(1.296)
|
0.46
(1.861)
|
-1.37
(1.337)
|
-1.24
(1.861)
|
-3.58
(1.316)
|
-2.88
(1.990)
|
-1.49
(1.460)
|
-1.76
(1.922)
|
-0.71
(0.554)
|
-0.10
(0.512)
|
| Title | Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks |
|---|---|
| Description | Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [mmol/L] |
-0.41
(0.369)
|
0.21
(0.531)
|
-0.43
(0.381)
|
-0.03
(0.531)
|
-0.82
(0.375)
|
-0.77
(0.567)
|
-0.15
(0.416)
|
-0.60
(0.548)
|
-0.34
(0.181)
|
-0.04
(0.189)
|
| Title | Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks |
|---|---|
| Description | Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [pmol/L] |
8.09
(22.673)
|
44.56
(32.561)
|
-55.07
(23.779)
|
11.33
(33.629)
|
5.13
(23.392)
|
-5.15
(36.123)
|
91.74
(25.065)
|
36.87
(33.629)
|
56.21
(27.952)
|
-26.43
(40.163)
|
| Title | Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks |
|---|---|
| Description | Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 32 | 16 | 31 | 15 | 31 | 14 | 26 | 15 | 28 | 21 |
| Least Squares Mean (Standard Error) [nmol/L] |
-0.04
(0.081)
|
-0.04
(0.116)
|
-0.10
(0.083)
|
0.16
(0.120)
|
-0.21
(0.082)
|
0.05
(0.124)
|
0.07
(0.089)
|
-0.14
(0.120)
|
-0.18
(0.101)
|
-0.18
(0.134)
|
| Title | Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks |
|---|---|
| Description | An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit. |
| Time Frame | Baseline, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment. |
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metformin + Sulfonylurea | Placebo + Metformin + Sulfonylurea | Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia | Placebo + Met + Sulfonyl + Thiaz | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Participants With IGT | Placebo in Participants With IGT |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. |
| Measure Participants | 33 | 17 | 32 | 17 | 32 | 16 | 28 | 15 | 28 | 26 |
| Number of Participants with Serious Adverse Events |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Number of Participants with Non-serious AEs > 5% |
0
0%
|
4
23.5%
|
6
18.2%
|
3
17.6%
|
4
12.5%
|
3
18.8%
|
6
21.4%
|
3
20%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Set included all randomized participants who received study drug. | |||||||||||||||||||
| Arm/Group Title | Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metforimin + Sulfonylurea | Placebo + Metforimin + Sulfonylurea | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | Placebo + Met + Sulfonyl + Thiazolidinedione | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Patients With IGT | Placebo in Patients With IGT | ||||||||||
| Arm/Group Description | Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening. | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening | Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metforimin + Sulfonylurea | Placebo + Metforimin + Sulfonylurea | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | Placebo + Met + Sulfonyl + Thiazolidinedione | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Patients With IGT | Placebo in Patients With IGT | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metforimin + Sulfonylurea | Placebo + Metforimin + Sulfonylurea | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | Placebo + Met + Sulfonyl + Thiazolidinedione | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Patients With IGT | Placebo in Patients With IGT | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Canakinumab 150 mg + Metformin | Placebo + Metformin | Canakinumab 150 mg + Metforimin + Sulfonylurea | Placebo + Metforimin + Sulfonylurea | Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione | Placebo + Met + Sulfonyl + Thiazolidinedione | Canakinumab 150 mg + Insulin | Placebo + Insulin | Canakinumab 150 mg in Patients With IGT | Placebo in Patients With IGT | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 4/17 (23.5%) | 6/32 (18.8%) | 3/17 (17.6%) | 4/32 (12.5%) | 3/16 (18.8%) | 6/28 (21.4%) | 3/15 (20%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Vertigo | 0/33 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Vision blurred | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 1/32 (3.1%) | 1/16 (6.3%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Visual impairment | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 1/16 (6.3%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Diarrhoea | 0/33 (0%) | 1/17 (5.9%) | 1/32 (3.1%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 1/15 (6.7%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Dyspepsia | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 1/15 (6.7%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Nausea | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 0/17 (0%) | 0/32 (0%) | 1/16 (6.3%) | 1/28 (3.6%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Bronchitis | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 1/15 (6.7%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Hordeolum | 0/33 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Nasopharyngitis | 0/33 (0%) | 2/17 (11.8%) | 0/32 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Pharyngitis | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 1/17 (5.9%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Antinuclear antibody positive | 0/33 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Hypoglycaemia | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/16 (0%) | 3/28 (10.7%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Dizziness | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 0/17 (0%) | 2/32 (6.3%) | 1/16 (6.3%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Tremor | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 1/17 (5.9%) | 2/32 (6.3%) | 0/16 (0%) | 2/28 (7.1%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Confusional state | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 1/17 (5.9%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Dysphonia | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 1/28 (3.6%) | 1/15 (6.7%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Hyperhidrosis | 0/33 (0%) | 0/17 (0%) | 1/32 (3.1%) | 0/17 (0%) | 2/32 (6.3%) | 1/16 (6.3%) | 1/28 (3.6%) | 0/15 (0%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
| Rash papular | 0/33 (0%) | 0/17 (0%) | 0/32 (0%) | 0/17 (0%) | 0/32 (0%) | 0/16 (0%) | 0/28 (0%) | 1/15 (6.7%) | 0/28 (0%) | 0/26 (0%) | ||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Dr. Tom Thuren/Global Brand Medical Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-1828 |
| tom.thuren@novartis.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01068860
Other Study ID Numbers:
- CACZ885I2207
First Posted:
Feb 15, 2010
Last Update Posted:
Sep 5, 2011
Last Verified:
Aug 1, 2011