Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01026194
Collaborator
(none)
204
1
2
18
11.4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III Study of MP-513 in Combination With Thiazolidinedione in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Jun 1, 2011
Actual Study Completion Date
:
Jun 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo / Teneli + Pio
|
Drug: Placebo / Teneli (Teneligliptin) + pio (pioglitazone)
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
|
| Experimental: Teneli / Teneli + pio
|
Drug: Teneli / Teneli + pio
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in HbA1c at Week 12 [at Week 0 and Week 12]
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Secondary Outcome Measures
- Change From Baseline in Fasting Plasma Glucose at Week 12 [at Week 0 and Week 12]
The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
- Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 [0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12]
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.
- Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 [at Week 0 and Week 12]
The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients who are 20 - 75 years old
-
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
-
Patients whose HbA1c is between 6.5% and 10.0%
-
Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
-
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion Criteria:
-
Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
-
Patients who are accepting treatments of arrhythmias
-
Patients with serious diabetic complications
-
Patients who are the excessive alcohol addicts
-
Patients with severe hepatic disorder or severe renal disorder.
-
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shinjukuku | Tokyo | Japan |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Corporation
Investigators
- Study Director: Takashi Kadowaki, Professor, Tokyo University
- Study Director: Kazuoki Kondo, MD, Mitsubishi Tanabe Pharma Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01026194
Other Study ID Numbers:
- 3000-A7
First Posted:
Dec 4, 2009
Last Update Posted:
Jan 16, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Mitsubishi Tanabe Pharma Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio |
|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. |
| Period Title: Period 1：Double Blind Period | ||
| STARTED | 101 | 103 |
| COMPLETED | 98 | 98 |
| NOT COMPLETED | 3 | 5 |
| Period Title: Period 1：Double Blind Period | ||
| STARTED | 98 | 98 |
| COMPLETED | 91 | 88 |
| NOT COMPLETED | 7 | 10 |
Baseline Characteristics
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio | Total |
|---|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Total of all reporting groups |
| Overall Participants | 101 | 103 | 204 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
61.1
(8.9)
|
59.7
(9.7)
|
60.4
(9.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
24.8%
|
35
34%
|
60
29.4%
|
| Male |
76
75.2%
|
68
66%
|
144
70.6%
|
Outcome Measures
| Title | Change From Baseline in HbA1c at Week 12 |
|---|---|
| Description | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. |
| Time Frame | at Week 0 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. |
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio |
|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. |
| Measure Participants | 101 | 103 |
| Least Squares Mean (Standard Error) [Percent of HbA1c] |
-0.20
(0.05)
|
-0.94
(0.04)
|
| Title | Change From Baseline in Fasting Plasma Glucose at Week 12 |
|---|---|
| Description | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. |
| Time Frame | at Week 0 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. |
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio |
|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. |
| Measure Participants | 101 | 103 |
| Least Squares Mean (Standard Error) [mg / dL] |
-4.5
(2.0)
|
-21.0
(1.9)
|
| Title | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 |
|---|---|
| Description | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. |
| Time Frame | 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. |
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio |
|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. |
| Measure Participants | 98 | 98 |
| Least Squares Mean (Standard Error) [mg*h / dL] |
-13.722
(5.134)
|
-85.031
(5.134)
|
| Title | Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 |
|---|---|
| Description | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. |
| Time Frame | at Week 0 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. |
| Arm/Group Title | Placebo/Teneli + Pio | Teneli/Teneli + Pio |
|---|---|---|
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. |
| Measure Participants | 98 | 98 |
| Least Squares Mean (Standard Error) [mg / dL] |
-5.6
(3.6)
|
-56.9
(3.6)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Placebo/Teneli + Pio (Data Through Week 12) | Teneli/Teneli + Pio (Data Through Week 12) | Placebo/Teneli + Pio (Data From Week 12 to Week 52) | Teneli/Teneli + Pio (Data Through Week 52) | ||||
| Arm/Group Description | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown. | Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown. | Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown. | ||||
All Cause Mortality |
||||||||
| Placebo/Teneli + Pio (Data Through Week 12) | Teneli/Teneli + Pio (Data Through Week 12) | Placebo/Teneli + Pio (Data From Week 12 to Week 52) | Teneli/Teneli + Pio (Data Through Week 52) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo/Teneli + Pio (Data Through Week 12) | Teneli/Teneli + Pio (Data Through Week 12) | Placebo/Teneli + Pio (Data From Week 12 to Week 52) | Teneli/Teneli + Pio (Data Through Week 52) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/101 (1%) | 4/103 (3.9%) | 3/98 (3.1%) | 11/103 (10.7%) | ||||
| Cardiac disorders | ||||||||
| Acute myocardial infarction | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Eye disorders | ||||||||
| Cataract | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Gastrointestinal disorders | ||||||||
| Colonic polyp | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Gastric polyps | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Haemorrhoids | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Gastric cancer | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Metastases to bone | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Oesophageal carcinoma | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Prostate cancer | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Large intestine carcinoma | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Ovarian cancer | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Nervous system disorders | ||||||||
| Loss of consciousness | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Carotid artery stenosis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Myelopathy | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Upper respiratory tract inflammation | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo/Teneli + Pio (Data Through Week 12) | Teneli/Teneli + Pio (Data Through Week 12) | Placebo/Teneli + Pio (Data From Week 12 to Week 52) | Teneli/Teneli + Pio (Data Through Week 52) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 47/101 (46.5%) | 63/103 (61.2%) | 89/98 (90.8%) | 88/103 (85.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Iron deficiency anaemia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Leukopenia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Cardiac disorders | ||||||||
| Bundle branch block left | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Cardiomegaly | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Atrial fibrillation | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Palpitations | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Cardiac valve disease | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Ear and labyrinth disorders | ||||||||
| Vertigo | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 1/101 (1%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Blepharitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Cataract | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Conjunctival haemorrhage | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Conjunctivitis allergic | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Corneal opacity | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Diabetic retinopathy | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 2/103 (1.9%) | ||||
| Dry eye | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Eyelid oedema | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Glaucoma | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Keratoconjunctivitis sicca | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Retinal vein occlusion | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Vision blurred | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Meibomian gland dysfunction | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Abdominal distension | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Abdominal pain upper | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Anal fissure | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Cheilitis | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Colonic polyp | 0/101 (0%) | 1/103 (1%) | 4/98 (4.1%) | 3/103 (2.9%) | ||||
| Constipation | 1/101 (1%) | 2/103 (1.9%) | 4/98 (4.1%) | 3/103 (2.9%) | ||||
| Dental caries | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Diarrhoea | 0/101 (0%) | 1/103 (1%) | 2/98 (2%) | 1/103 (1%) | ||||
| Gastric polyps | 0/101 (0%) | 1/103 (1%) | 1/98 (1%) | 4/103 (3.9%) | ||||
| Gastritis | 0/101 (0%) | 2/103 (1.9%) | 4/98 (4.1%) | 6/103 (5.8%) | ||||
| Gingival swelling | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Reflux oesophagitis | 0/101 (0%) | 2/103 (1.9%) | 4/98 (4.1%) | 4/103 (3.9%) | ||||
| Stomatitis | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Gastric xanthoma | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Abdominal pain lower | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Duodenal ulcer | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Enterocolitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Flatulence | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Gastric ulcer | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 3/103 (2.9%) | ||||
| Gastritis atrophic | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Gastritis erosive | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Gingivitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 3/103 (2.9%) | ||||
| Haemorrhoids | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 3/103 (2.9%) | ||||
| Nausea | 0/101 (0%) | 0/103 (0%) | 3/98 (3.1%) | 1/103 (1%) | ||||
| Periodontal disease | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Periodontitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 4/103 (3.9%) | ||||
| Supernumerary teeth | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Vomiting | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Gastric mucosal lesion | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Erosive oesophagitis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| General disorders | ||||||||
| Chest discomfort | 1/101 (1%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Oedema peripheral | 6/101 (5.9%) | 2/103 (1.9%) | 4/98 (4.1%) | 4/103 (3.9%) | ||||
| Pyrexia | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Chest pain | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Feeling abnormal | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Malaise | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Mass | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Thirst | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Hepatobiliary disorders | ||||||||
| Hepatic steatosis | 0/101 (0%) | 1/103 (1%) | 2/98 (2%) | 3/103 (2.9%) | ||||
| Cholelithiasis | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Hepatic congestion | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Hyperplastic cholecystopathy | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Immune system disorders | ||||||||
| Seasonal allergy | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Infections and infestations | ||||||||
| Abscess | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Acute tonsillitis | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Bronchitis | 2/101 (2%) | 1/103 (1%) | 4/98 (4.1%) | 2/103 (1.9%) | ||||
| Cystitis | 3/101 (3%) | 1/103 (1%) | 2/98 (2%) | 4/103 (3.9%) | ||||
| Nasal abscess | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Nasopharyngitis | 8/101 (7.9%) | 12/103 (11.7%) | 33/98 (33.7%) | 33/103 (32%) | ||||
| Pharyngitis | 0/101 (0%) | 1/103 (1%) | 3/98 (3.1%) | 2/103 (1.9%) | ||||
| Pneumonia | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Tonsillitis | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Gastritis viral | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Herpes dermatitis | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Oral herpes | 1/101 (1%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Folliculitis | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Gastroenteritis | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Herpes simplex | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Hordeolum | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Influenza | 0/101 (0%) | 0/103 (0%) | 3/98 (3.1%) | 0/103 (0%) | ||||
| Laryngitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Oesophageal candidiasis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Onychomycosis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Otitis externa | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Paronychia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Parotitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Rhinitis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Sinusitis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Tinea pedis | 0/101 (0%) | 0/103 (0%) | 3/98 (3.1%) | 0/103 (0%) | ||||
| Urethritis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Gingival abscess | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Helicobacter infection | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 3/103 (2.9%) | ||||
| Tinea versicolour | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Bone abscess | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Animal bite | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Joint sprain | 2/101 (2%) | 2/103 (1.9%) | 4/98 (4.1%) | 5/103 (4.9%) | ||||
| Scratch | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Thoracic vertebral fracture | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Contusion | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 4/103 (3.9%) | ||||
| Post procedural complication | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Open wound | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Arthropod sting | 0/101 (0%) | 0/103 (0%) | 3/98 (3.1%) | 3/103 (2.9%) | ||||
| Bite | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Nail avulsion | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Radius fracture | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Excoriation | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Iliotibial band syndrome | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Heat illness | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Investigations | ||||||||
| Blood calcium decreased | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Blood creatine phosphokinase increased | 2/101 (2%) | 3/103 (2.9%) | 4/98 (4.1%) | 9/103 (8.7%) | ||||
| Blood triglycerides increased | 1/101 (1%) | 2/103 (1.9%) | 1/98 (1%) | 5/103 (4.9%) | ||||
| Blood urea increased | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Blood uric acid increased | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Gamma-glutamyltransferase increased | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Glucose urine present | 8/101 (7.9%) | 3/103 (2.9%) | 6/98 (6.1%) | 7/103 (6.8%) | ||||
| Blood urine present | 2/101 (2%) | 3/103 (2.9%) | 5/98 (5.1%) | 12/103 (11.7%) | ||||
| White blood cell count increased | 0/101 (0%) | 1/103 (1%) | 2/98 (2%) | 1/103 (1%) | ||||
| Protein urine present | 1/101 (1%) | 4/103 (3.9%) | 3/98 (3.1%) | 9/103 (8.7%) | ||||
| Urine ketone body present | 2/101 (2%) | 0/103 (0%) | 6/98 (6.1%) | 2/103 (1.9%) | ||||
| Occult blood positive | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hypoglycaemia | 0/101 (0%) | 2/103 (1.9%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Hyperphosphatasaemia | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Dehydration | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Gout | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Hyperuricaemia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Hyperlipidaemia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/101 (1%) | 0/103 (0%) | 2/98 (2%) | 3/103 (2.9%) | ||||
| Back pain | 1/101 (1%) | 2/103 (1.9%) | 6/98 (6.1%) | 7/103 (6.8%) | ||||
| Haemarthrosis | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Muscle spasms | 0/101 (0%) | 2/103 (1.9%) | 1/98 (1%) | 3/103 (2.9%) | ||||
| Myalgia | 0/101 (0%) | 2/103 (1.9%) | 3/98 (3.1%) | 2/103 (1.9%) | ||||
| Neck pain | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Osteoarthritis | 0/101 (0%) | 2/103 (1.9%) | 1/98 (1%) | 3/103 (2.9%) | ||||
| Pain in extremity | 1/101 (1%) | 1/103 (1%) | 3/98 (3.1%) | 0/103 (0%) | ||||
| Periarthritis | 0/101 (0%) | 1/103 (1%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Spinal osteoarthritis | 1/101 (1%) | 1/103 (1%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Tenosynovitis | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Intervertebral disc protrusion | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Musculoskeletal stiffness | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Groin pain | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Lumbar spinal stenosis | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 1/103 (1%) | ||||
| Osteoporosis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Plantar fasciitis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Scoliosis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Spinal column stenosis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Tendonitis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Trigger finger | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Spondylolisthesis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Thyroid neoplasm | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Ovarian neoplasm | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Nervous system disorders | ||||||||
| Cervicobrachial syndrome | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Dizziness | 1/101 (1%) | 0/103 (0%) | 4/98 (4.1%) | 3/103 (2.9%) | ||||
| Headache | 1/101 (1%) | 2/103 (1.9%) | 3/98 (3.1%) | 2/103 (1.9%) | ||||
| Hypoaesthesia | 1/101 (1%) | 1/103 (1%) | 3/98 (3.1%) | 2/103 (1.9%) | ||||
| Neuralgia | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Tension headache | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Lacunar infarction | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Spinocerebellar disorder | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Cerebrovascular stenosis | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Carotid artery stenosis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Intercostal neuralgia | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| VIIth nerve paralysis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Carotid arteriosclerosis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Occipital neuralgia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 1/101 (1%) | 0/103 (0%) | 4/98 (4.1%) | 2/103 (1.9%) | ||||
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 0/101 (0%) | 1/103 (1%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Calculus urinary | 0/101 (0%) | 0/103 (0%) | 2/98 (2%) | 0/103 (0%) | ||||
| Dysuria | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Hypertonic bladder | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Nocturia | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Pollakiuria | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Diabetic nephropathy | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Calculus prostatic | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Erectile dysfunction | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/101 (2%) | 1/103 (1%) | 2/98 (2%) | 3/103 (2.9%) | ||||
| Upper respiratory tract inflammation | 1/101 (1%) | 4/103 (3.9%) | 10/98 (10.2%) | 11/103 (10.7%) | ||||
| Oropharyngeal discomfort | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Asthma | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Epistaxis | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Rhinitis allergic | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
| Dermatitis allergic | 0/101 (0%) | 2/103 (1.9%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Dry skin | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Eczema | 0/101 (0%) | 2/103 (1.9%) | 4/98 (4.1%) | 6/103 (5.8%) | ||||
| Eczema asteatotic | 1/101 (1%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Heat rash | 0/101 (0%) | 1/103 (1%) | 1/98 (1%) | 2/103 (1.9%) | ||||
| Ingrowing nail | 0/101 (0%) | 1/103 (1%) | 1/98 (1%) | 1/103 (1%) | ||||
| Pruritus | 0/101 (0%) | 2/103 (1.9%) | 0/98 (0%) | 3/103 (2.9%) | ||||
| Rash | 1/101 (1%) | 1/103 (1%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Skin exfoliation | 1/101 (1%) | 0/103 (0%) | 0/98 (0%) | 0/103 (0%) | ||||
| Urticaria | 0/101 (0%) | 2/103 (1.9%) | 0/98 (0%) | 2/103 (1.9%) | ||||
| Dandruff | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Dermatitis atopic | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Dermatitis contact | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 1/103 (1%) | ||||
| Eczema nummular | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Pityriasis rosea | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Seborrhoeic dermatitis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Xeroderma | 0/101 (0%) | 0/103 (0%) | 1/98 (1%) | 0/103 (0%) | ||||
| Photodermatosis | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Hyperkeratosis palmaris and plantaris | 0/101 (0%) | 0/103 (0%) | 0/98 (0%) | 1/103 (1%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/101 (1%) | 0/103 (0%) | 2/98 (2%) | 1/103 (1%) | ||||
| Hypotension | 0/101 (0%) | 1/103 (1%) | 0/98 (0%) | 1/103 (1%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trials, Information Desk |
|---|---|
| Organization | Mitsubishi Tanabe Pharma Corporation |
| Phone | |
| cti-inq-ml@ml.mt-pharma.co.jp |
Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01026194
Other Study ID Numbers:
- 3000-A7
First Posted:
Dec 4, 2009
Last Update Posted:
Jan 16, 2014
Last Verified:
Jan 1, 2014