| Primary | Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to 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. | 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. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG004 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00024
- OG00124
- OG00224
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.0005± 0.00622
- OG0010.0029± 0.00882
- OG0020.0007± 0.00692
- OG003
|
|
| |
| Secondary | Change in Body Weight From Baseline to Week 12 | Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported. | 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. | Posted | | Mean | Standard Deviation | Kilogram | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment D: BMS-986036 (20 mg Daily) | |
|
| Secondary | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index) | 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. | 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. | Posted | | Mean | Standard Deviation | Unit on a scale | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 |
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| Secondary | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. | 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. | Posted | | Mean | Standard Deviation | Unit on a Scale | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | |
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| Secondary | Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI) | 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)). | 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. | Posted | | Mean | Standard Deviation | Unit on a scale | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. |
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| 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 | 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). | 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. | Posted | | Mean | Standard Deviation | Millimole*hour per Liter (mmol*hr/L) | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG003 |
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| Secondary | Change in OGTT Insulin AUC (0-2 Hours) From Baseline to 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). | 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. | Posted | | Mean | Standard Deviation | mmol*hr/L | | Bseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment D: BMS-986036 (20 mg Daily) |
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| Secondary | Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to 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). | 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. | Posted | | Mean | Standard Deviation | mmol*hr/L | | Baseline (Day 1) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: Placebo | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment D: BMS-986036 (20 mg Daily) |
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| Secondary | Average Concentration (Cavg) of C-terminal Intact BMS-986036 | Cavg of C-terminal Intact BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per Liter (ug/L) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) |
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| Secondary | Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036 | Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram/liter | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) |
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| 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 | AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/liter | | Pre-dose, 6, 24 hours postdose on Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) |
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| 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 | AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/liter | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 |
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| Secondary | Average Concentration (Cavg) of Total BMS-986036 | Cavg of Total BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per Liter (ug/L) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) | |
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| Secondary | Maximum Observed Concentration (Cmax) of Total BMS-986036 | Maximum observed concentration (Cmax) of Total BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | microgram/liter | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036 | AUC [0-24 hours, ss] of Total BMS-986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/liter | | Pre-dose, 6, 24 hours postdose on Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) | |
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| 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 | AUC [0-168 hours, ss] of Total BMS- 986036 was reported. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/liter | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) |
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| Secondary | Percentage of Participants With ANTI-BMS-986036 Antibody Response | 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. | It included all treated participants who were randomized to treatment and subsequently received at least one dose of study medication. | Posted | | Number | | Percentage of participants | | Baseline and Day 126 | | | | ID | Title | Description |
|---|
| OG000 | Treatment B: BMS-986036 (1 mg Daily) | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks. | | OG001 | Treatment C: BMS-986036 (5 mg Daily) | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks. | | OG002 | Treatment D: BMS-986036 (20 mg Daily) | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks. | | OG003 | Treatment E: BMS-986036 (20 mg Weekly) | |
|