A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02097277
Collaborator
(none)
219
16
5
25.1
13.7
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Obese Adults With Type-2 Diabetes
Actual Study Start Date
:
Apr 15, 2014
Actual Primary Completion Date
:
Sep 22, 2015
Actual Study Completion Date
:
May 17, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Treatment A: Placebo (Matching with BMS-986036 - Daily) Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks |
Biological: Placebo (Matching with BMS-986036)
|
| Experimental: Arm 2: Treatment B: BMS-986036 (1 mg Daily) BMS-986036 1 mg subcutaneous injection once daily for 12 weeks |
Biological: BMS-986036
|
| Experimental: Treatment C: BMS-986036 (5 mg Daily) BMS-986036 5 mg subcutaneous injection once daily for 12 weeks |
Biological: BMS-986036
|
| Experimental: Treatment D: BMS-986036 (20 mg Daily) BMS-986036 20 mg subcutaneous injection once daily for 12 weeks |
Biological: BMS-986036
|
| Experimental: Treatment E: BMS-986036 (20 mg Weekly) BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks |
Biological: BMS-986036
Biological: Placebo (Matching with BMS-986036)
|
Outcome Measures
Primary Outcome Measures
- Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 [Baseline (Day 1) and Week 12]
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.
Secondary Outcome Measures
- Change in Body Weight From Baseline to Week 12 [Baseline (Day 1) and Week 12]
Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index) [Baseline (Day 1) and Week 12]
Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*3+PG120*2)/8*(FPI+PI30*2+PI60*3+PI120*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Baseline (Day 1) and Week 12]
Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.
- Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) [Baseline (Day 1) and Week 12]
The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).
- Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12 [Baseline (Day 1) and Week 12]
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).
- Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12 [Bseline (Day 1) and Week 12]
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).
- Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12 [Baseline (Day 1) and Week 12]
Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).
- Average Concentration (Cavg) of C-terminal Intact BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
Cavg of C-terminal Intact BMS-986036 was reported.
- Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.
- Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8]
AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported.
- Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported.
- Average Concentration (Cavg) of Total BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
Cavg of Total BMS-986036 was reported.
- Maximum Observed Concentration (Cmax) of Total BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
Maximum observed concentration (Cmax) of Total BMS-986036 was reported.
- Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8]
AUC [0-24 hours, ss] of Total BMS-986036 was reported.
- Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036 [Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)]
AUC [0-168 hours, ss] of Total BMS- 986036 was reported.
- Percentage of Participants With ANTI-BMS-986036 Antibody Response [Baseline and Day 126]
Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-
Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
-
Body mass index 30.0 to 50.0
Exclusion Criteria:
-
Any significant acute or chronic medical illness
-
Inability to self-administer subcutaneous injections
-
Inability to be venipunctured
-
Evidence of organ dysfunction beyond what is consistent with the target population
-
History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Clinical Research | Little Rock | Arkansas | United States | 72205 |
| 2 | Anaheim Clinical Trials Llc | Anaheim | California | United States | 92801 |
| 3 | National Research Institute | Los Angeles | California | United States | 90057 |
| 4 | Encompass Clinical Research | Spring Valley | California | United States | 91978-1522 |
| 5 | Encompass Clinical Research | Spring Valley | California | United States | 91978 |
| 6 | All Medical Research, Llc | Cooper City | Florida | United States | 33024 |
| 7 | Central Kentucky Research Associates, Inc. | Lexington | Kentucky | United States | 40509 |
| 8 | Premier Research | Trenton | New Jersey | United States | 08611 |
| 9 | Metrolina Internal Medicine | Charlotte | North Carolina | United States | 28204 |
| 10 | Sterling Research Grp, Ltd. | Cincinnati | Ohio | United States | 45219 |
| 11 | Manna Research Vancouver | Vancouver | British Columbia | Canada | V6J 1S3 |
| 12 | Aggarwal And Associates | Brampton | Ontario | Canada | L6T 0G1 |
| 13 | Rhodin Recherche Clinique | Drummondville | Quebec | Canada | J2B 7T1 |
| 14 | Recherche Gcp Research | Montreal | Quebec | Canada | H1M 1B1 |
| 15 | Medexa Recherche | Victoriaville | Quebec | Canada | G6P 6P6 |
| 16 | Alpha-Recherche Clinique | Quebec | Canada | G3K 2P8 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02097277
Other Study ID Numbers:
- MB130-002
First Posted:
Mar 27, 2014
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 219 participants were enrolled; 138 entered the lead-in period. Reasons for not entering lead-in period included "not meeting study eligibility criteria". 120 were randomized to treatment. Reasons not randomized: 6 withdrew consent, 2 lost to follow-up, 4 no longer met study criteria, 1 due to admin.reason by Sponsor and 4 due to other reasons. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks |
| Period Title: Overall Study | |||||
| STARTED | 24 | 24 | 24 | 24 | 24 |
| COMPLETED | 22 | 21 | 22 | 20 | 23 |
| NOT COMPLETED | 2 | 3 | 2 | 4 | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. | Total of all reporting groups |
| Overall Participants | 24 | 24 | 24 | 24 | 24 | 120 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
57.9
(7.58)
|
55.4
(9.44)
|
55.3
(9.92)
|
56.2
(8.17)
|
55.2
(12.62)
|
56.0
(9.60)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
10
41.7%
|
11
45.8%
|
11
45.8%
|
9
37.5%
|
12
50%
|
53
44.2%
|
| Male |
14
58.3%
|
13
54.2%
|
13
54.2%
|
15
62.5%
|
12
50%
|
67
55.8%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
4.2%
|
3
12.5%
|
2
8.3%
|
4
16.7%
|
10
8.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
8.3%
|
3
12.5%
|
3
12.5%
|
2
8.3%
|
5
20.8%
|
15
12.5%
|
| White |
22
91.7%
|
20
83.3%
|
18
75%
|
20
83.3%
|
15
62.5%
|
95
79.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 |
|---|---|
| Description | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported. |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Percent Change] |
0.0005
(0.00622)
|
0.0029
(0.00882)
|
0.0007
(0.00692)
|
0.0004
(0.00814)
|
-0.0004
(0.00418)
|
| Title | Change in Body Weight From Baseline to Week 12 |
|---|---|
| Description | Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported. |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only subjects with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Kilogram] |
-0.22
(2.615)
|
-0.26
(1.718)
|
-0.10
(2.883)
|
-1.09
(2.583)
|
-0.50
(2.297)
|
| Title | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index) |
|---|---|
| Description | Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*3+PG120*2)/8*(FPI+PI30*2+PI60*3+PI120*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load. |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Unit on a scale] |
-0.18
(0.967)
|
-0.19
(1.348)
|
-0.18
(2.102)
|
0.77
(2.455)
|
0.54
(1.772)
|
| Title | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
|---|---|
| Description | Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405. |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Unit on a Scale] |
-0.19
(4.136)
|
0.00
(5.633)
|
-1.88
(8.940)
|
-1.73
(4.589)
|
-0.34
(3.707)
|
| Title | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) |
|---|---|
| Description | The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)). |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Unit on a scale] |
0.00
(0.011)
|
0.00
(0.010)
|
0.00
(0.015)
|
0.00
(0.016)
|
0.00
(0.011)
|
| Title | Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12 |
|---|---|
| Description | Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC). |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [Millimole*hour per Liter (mmol*hr/L)] |
1.538
(4.2940)
|
2.594
(5.8193)
|
-0.646
(7.0591)
|
-0.215
(4.7397)
|
-2.293
(4.9322)
|
| Title | Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12 |
|---|---|
| Description | Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC). |
| Time Frame | Bseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [mmol*hr/L] |
-64.648
(231.6043)
|
-72.155
(277.4819)
|
-83.850
(215.3974)
|
-58.313
(205.1879)
|
-150.679
(257.5965)
|
| Title | Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12 |
|---|---|
| Description | Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC). |
| Time Frame | Baseline (Day 1) and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure. |
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 | 24 |
| Mean (Standard Deviation) [mmol*hr/L] |
-0.287
(1.2463)
|
0.031
(1.3926)
|
-0.181
(0.8927)
|
-0.169
(1.0176)
|
-0.750
(1.2224)
|
| Title | Average Concentration (Cavg) of C-terminal Intact BMS-986036 |
|---|---|
| Description | Cavg of C-terminal Intact BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [Microgram per Liter (ug/L)] |
50.6
(60.6)
|
204
(50.4)
|
762
(49.2)
|
197
(60.5)
|
| Title | Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036 |
|---|---|
| Description | Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram/liter] |
53.3
(61.2)
|
213
(50.4)
|
807
(48.8)
|
459
(41.4)
|
| Title | Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036 |
|---|---|
| Description | AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [hour*microgram/liter] |
1210
(60.6)
|
4900
(50.4)
|
18300
(49.2)
|
| Title | Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036 |
|---|---|
| Description | AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 0 | 0 | 0 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [hour*microgram/liter] |
31800
(57.6)
|
| Title | Average Concentration (Cavg) of Total BMS-986036 |
|---|---|
| Description | Cavg of Total BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [Microgram per Liter (ug/L)] |
342
(42.3)
|
1560
(44.6)
|
6390
(43.2)
|
1130
(38.9)
|
| Title | Maximum Observed Concentration (Cmax) of Total BMS-986036 |
|---|---|
| Description | Maximum observed concentration (Cmax) of Total BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram/liter] |
344
(42.5)
|
1570
(44.5)
|
6440
(43.1)
|
1420
(36.1)
|
| Title | Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036 |
|---|---|
| Description | AUC [0-24 hours, ss] of Total BMS-986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 21 | 22 | 20 | 0 |
| Geometric Mean (Geometric Coefficient of Variation) [hour*microgram/liter] |
8200
(42.3)
|
37400
(44.6)
|
153000
(43.2)
|
| Title | Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036 |
|---|---|
| Description | AUC [0-168 hours, ss] of Total BMS- 986036 was reported. |
| Time Frame | Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 0 | 0 | 0 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [hour*microgram/liter] |
172000
(39.1)
|
| Title | Percentage of Participants With ANTI-BMS-986036 Antibody Response |
|---|---|
| Description | Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay. |
| Time Frame | Baseline and Day 126 |
Outcome Measure Data
| Analysis Population Description |
|---|
| It included all treated participants who were randomized to treatment and subsequently received at least one dose of study medication. |
| Arm/Group Title | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) |
|---|---|---|---|---|
| Arm/Group Description | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. |
| Measure Participants | 24 | 24 | 24 | 24 |
| ADA Positive |
37.5
156.3%
|
79.2
330%
|
83.3
347.1%
|
58.3
242.9%
|
| ADA Negative |
62.5
260.4%
|
16.7
69.6%
|
12.5
52.1%
|
37.5
156.3%
|
Adverse Events
| Time Frame | Approximately 2 years | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) | |||||
| Arm/Group Description | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks. | |||||
All Cause Mortality |
||||||||||
| Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | |||||
Serious Adverse Events |
||||||||||
| Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | |||||
| Cardiac disorders | ||||||||||
| Mitral Valve Disease | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | |||||
| Tricuspid Valve Disease | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal Cell Carcinoma | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Treatment A: Placebo | Treatment B: BMS-986036 (1 mg Daily) | Treatment C: BMS-986036 (5 mg Daily) | Treatment D: BMS-986036 (20 mg Daily) | Treatment E: BMS-986036 (20 mg Weekly) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/24 (37.5%) | 12/24 (50%) | 7/24 (29.2%) | 10/24 (41.7%) | 10/24 (41.7%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhea | 1/24 (4.2%) | 3/24 (12.5%) | 2/24 (8.3%) | 4/24 (16.7%) | 5/24 (20.8%) | |||||
| Nausea | 0/24 (0%) | 2/24 (8.3%) | 0/24 (0%) | 1/24 (4.2%) | 3/24 (12.5%) | |||||
| Dyspepsia | 0/24 (0%) | 3/24 (12.5%) | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | |||||
| Vomiting | 0/24 (0%) | 2/24 (8.3%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | |||||
| General disorders | ||||||||||
| Injection Site Bruising | 5/24 (20.8%) | 6/24 (25%) | 4/24 (16.7%) | 1/24 (4.2%) | 3/24 (12.5%) | |||||
| Injection Site Erythema | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 2/24 (8.3%) | 1/24 (4.2%) | |||||
| Fatigue | 0/24 (0%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 2/24 (8.3%) | |||||
| Hunger | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) | 2/24 (8.3%) | 0/24 (0%) | |||||
| Infections and infestations | ||||||||||
| Nasopharyngitis | 1/24 (4.2%) | 3/24 (12.5%) | 1/24 (4.2%) | 1/24 (4.2%) | 2/24 (8.3%) | |||||
| Upper Respiratory Tract Infection | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) | 0/24 (0%) | 1/24 (4.2%) | |||||
| Investigations | ||||||||||
| Blood Creatine Phosphokinase Increased | 0/24 (0%) | 2/24 (8.3%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Increased Appetite | 2/24 (8.3%) | 1/24 (4.2%) | 3/24 (12.5%) | 1/24 (4.2%) | 1/24 (4.2%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 2/24 (8.3%) | 1/24 (4.2%) | 1/24 (4.2%) | 0/24 (0%) | 1/24 (4.2%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 2/24 (8.3%) | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 1/24 (4.2%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bristol-Myers Squibb |
| Phone | |
| clinical.trials@bms.com |
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02097277
Other Study ID Numbers:
- MB130-002
First Posted:
Mar 27, 2014
Last Update Posted:
Jul 31, 2019
Last Verified:
Jul 1, 2019