Trial · NCT02097277
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| 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 | Pre-dose, 6, 24 hours postdose on Week 8 | AUC \[0-24 hours, ss\] of C-terminal Intact BMS-986036 was reported. |
| 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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