Trial · NCT02097277
A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
NCT02097277, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2019-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes. Trials, record NCT02097277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02097277
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
- NCT number
- NCT02097277
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 219 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- BMS-986036, Placebo (Matching with BMS-986036)
- First posted
- 2014-03-27
- Last updated
- 2019-07-31
- Results first posted
- 2019-05-09
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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)). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Baseline (Day 1) and Week 12 | 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. | Percent Change | MEAN |
| SECONDARY | Change in Body Weight From Baseline to Week 12 | Baseline (Day 1) and Week 12 | 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. | Kilogram | MEAN |
| SECONDARY | 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 | 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. | Unit on a scale | MEAN |
| SECONDARY | 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 | 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. | Unit on a Scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) | Baseline (Day 1) and Week 12 | 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. | Unit on a scale | MEAN |
| SECONDARY | 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 | 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. | Millimole*hour per Liter (mmol*hr/L) | MEAN |
| SECONDARY | Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12 | Bseline (Day 1) and Week 12 | 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. | mmol*hr/L | MEAN |
| SECONDARY | Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12 | Baseline (Day 1) and Week 12 | 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. | mmol*hr/L | MEAN |
| SECONDARY | 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) | 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. | Microgram per Liter (ug/L) | GEOMETRIC_MEAN |
| SECONDARY | 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) | 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. | microgram/liter | GEOMETRIC_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Treatment A: Placebo | 0.0005 | Standard Deviation 0.00622 | Percent Change | |
| Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Treatment B: BMS-986036 (1 mg Daily) | 0.0029 | Standard Deviation 0.00882 | Percent Change | |
| Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Treatment C: BMS-986036 (5 mg Daily) | 0.0007 | Standard Deviation 0.00692 | Percent Change | |
| Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Treatment D: BMS-986036 (20 mg Daily) | 0.0004 | Standard Deviation 0.00814 | Percent Change | |
| Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Treatment E: BMS-986036 (20 mg Weekly) | -0.0004 | Standard Deviation 0.00418 | Percent Change | |
| Change in Body Weight From Baseline to Week 12 | Treatment A: Placebo | -0.22 | Standard Deviation 2.615 | Kilogram | |
| Change in Body Weight From Baseline to Week 12 | Treatment B: BMS-986036 (1 mg Daily) | -0.26 | Standard Deviation 1.718 | Kilogram | |
| Change in Body Weight From Baseline to Week 12 | Treatment C: BMS-986036 (5 mg Daily) | -0.10 | Standard Deviation 2.883 | Kilogram | |
| Change in Body Weight From Baseline to Week 12 | Treatment D: BMS-986036 (20 mg Daily) | -1.09 | Standard Deviation 2.583 | Kilogram | |
| Change in Body Weight From Baseline to Week 12 | Treatment E: BMS-986036 (20 mg Weekly) | -0.50 | Standard Deviation 2.297 | Kilogram |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment A: Placebo | 24 | |
| Overall Study | STARTED | Treatment B: BMS-986036 (1 mg Daily) | 24 | |
| Overall Study | STARTED | Treatment C: BMS-986036 (5 mg Daily) | 24 | |
| Overall Study | STARTED | Treatment D: BMS-986036 (20 mg Daily) | 24 | |
| Overall Study | STARTED | Treatment E: BMS-986036 (20 mg Weekly) | 24 | |
| Overall Study | COMPLETED | Treatment A: Placebo | 22 | |
| Overall Study | COMPLETED | Treatment B: BMS-986036 (1 mg Daily) | 21 | |
| Overall Study | COMPLETED | Treatment C: BMS-986036 (5 mg Daily) | 22 | |
| Overall Study | COMPLETED | Treatment D: BMS-986036 (20 mg Daily) | 20 | |
| Overall Study | COMPLETED | Treatment E: BMS-986036 (20 mg Weekly) | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection Site Bruising | General disorders | Treatment A: Placebo | 5 | 24 | |
| other | Injection Site Bruising | General disorders | Treatment B: BMS-986036 (1 mg Daily) | 6 | 24 | |
| other | Injection Site Bruising | General disorders | Treatment C: BMS-986036 (5 mg Daily) | 4 | 24 | |
| other | Injection Site Bruising | General disorders | Treatment D: BMS-986036 (20 mg Daily) | 1 | 24 | |
| other | Injection Site Bruising | General disorders | Treatment E: BMS-986036 (20 mg Weekly) | 3 | 24 | |
| other | Injection Site Erythema | General disorders | Treatment A: Placebo | 1 | 24 | |
| other | Injection Site Erythema | General disorders | Treatment B: BMS-986036 (1 mg Daily) | 1 | 24 | |
| other | Injection Site Erythema | General disorders | Treatment C: BMS-986036 (5 mg Daily) | 0 | 24 | |
| other | Injection Site Erythema | General disorders | Treatment D: BMS-986036 (20 mg Daily) | 2 | 24 | |
| other | Injection Site Erythema | General disorders | Treatment E: BMS-986036 (20 mg Weekly) | 1 | 24 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A: Placebo | 0 | 24 |
| Total, all-cause mortality | Treatment B: BMS-986036 (1 mg Daily) | 0 | 24 |
| Total, all-cause mortality | Treatment C: BMS-986036 (5 mg Daily) | 0 | 24 |
| Total, all-cause mortality | Treatment D: BMS-986036 (20 mg Daily) | 0 | 24 |
| Total, all-cause mortality | Treatment E: BMS-986036 (20 mg Weekly) | 0 | 24 |
| Total, other adverse events | Treatment A: Placebo | 9 | 24 |
| Total, other adverse events | Treatment B: BMS-986036 (1 mg Daily) | 12 | 24 |
| Total, other adverse events | Treatment C: BMS-986036 (5 mg Daily) | 7 | 24 |
| Total, other adverse events | Treatment D: BMS-986036 (20 mg Daily) | 10 | 24 |
| Total, other adverse events | Treatment E: BMS-986036 (20 mg Weekly) | 10 | 24 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30520566 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT02097277
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