Phase 2
N=120
A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02097277 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
May 2019
Primary outcome: Primary: Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 — 0.0005; 0.0029; 0.0007; 0.0004 Percent Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986036 (Biological); Placebo (Matching with BMS-986036) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12 |
0.0005; 0.0029; 0.0007; 0.0004; -0.0004 | — |
| SECONDARY Change in Body Weight From Baseline to Week 12 |
-0.22; -0.26; -0.10; -1.09; -0.50 | — |
| SECONDARY Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index) |
-0.18; -0.19; -0.18; 0.77; 0.54 | — |
| SECONDARY Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
-0.19; 0.00; -1.88; -1.73; -0.34 | — |
| SECONDARY Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) |
0.00; 0.00; 0.00; 0.00; 0.00 | — |
| 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 |
1.538; 2.594; -0.646; -0.215; -2.293 | — |
| SECONDARY Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12 |
-64.648; -72.155; -83.850; -58.313; -150.679 | — |
| SECONDARY Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12 |
-0.287; 0.031; -0.181; -0.169; -0.750 | — |
| SECONDARY Average Concentration (Cavg) of C-terminal Intact BMS-986036 |
50.6; 204; 762; 197 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036 |
53.3; 213; 807; 459 | — |
| SECONDARY 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 |
1210; 4900; 18300 | — |
| SECONDARY 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 |
31800 | — |
| SECONDARY Average Concentration (Cavg) of Total BMS-986036 |
342; 1560; 6390; 1130 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Total BMS-986036 |
344; 1570; 6440; 1420 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036 |
8200; 37400; 153000 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036 |
172000 | — |
| SECONDARY Percentage of Participants With ANTI-BMS-986036 Antibody Response |
37.5; 79.2; 83.3; 58.3; 62.5; 16.7 | — |
Summary
The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02097277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.