Obesity
Conditions
Keywords
exenatide, obesity, diabetes, Amylin, Lilly
Brief summary
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Interventions
DRUGexenatide
subcutaneous injection (5mcg or 10mcg), twice a day
DRUGplacebo
subcutaneous injection (equivalent volume to active dose), twice a day
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a Body Mass Index (BMI) \>= 30kg/m\^2
Exclusion criteria
* Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs * Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry) * Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months * Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening * Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening * Are actively participating in, or have participated in a formal weight loss program within the last 3 months * Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics * Have been treated with any anti-diabetic medications within 3 months of screening * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start * Have had bariatric surgery * Have had an organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 24 weeks | Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | 24 weeks | Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0) |
| Change in Waist-to-hip Ratio | 24 weeks | Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint. |
| Percentage of Patients Experiencing >=5% Weight Loss | 24 weeks | Percentage of exenatide and placebo treated patients experiencing \>=5% weight loss after 24 weeks of treatment (i.e., \[weight at week 0 minus weight at week 24\] divided by weight at week 0 times 100% \>=5%) |
| Change in Total Cholesterol | 24 weeks | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0) |
| Change in High Density Lipoprotein (HDL) Cholesterol | 24 weeks | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0) |
| Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | 24 weeks | Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0) |
| Change in Low Density Lipoprotein (LDL) Cholesterol | 24 weeks | Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0) |
| Change in Glycosylated Hemoglobin (HbA1c) | 24 weeks | Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0) |
| Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | 24 weeks | Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0) |
| Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) | 24 weeks | Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function. |
| Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) | 24 weeks | Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity. |
| Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | 24 weeks | Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24 |
| Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | 24 weeks | Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24 |
| Change in High Sensitivity C-reactive Protein (hsCRP) | 24 weeks | Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0) |
| Change in Fasting Serum Glucose | 24 weeks | Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0) |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Subject recruitment occurred between July 2007 and August 2007 at medical clinics in the United States.
Pre-assignment details
Prior to randomization, subjects participated in a 1-week, single-blind placebo lead-in period.
Participants by arm
| Arm | Count |
|---|---|
| Group A (Exenatide) exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP | 73 |
| Group B (Placebo) placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP | 79 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 3 |
| Overall Study | Lost to Follow-up | 10 | 10 |
| Overall Study | Protocol Violation | 2 | 4 |
| Overall Study | Sponsor Decision | 2 | 0 |
| Overall Study | Subject Decision | 10 | 17 |
Baseline characteristics
| Characteristic | Group A (Exenatide) | Group B (Placebo) | Total |
|---|---|---|---|
| Age, Continuous | 47.01 years STANDARD_DEVIATION 10.95 | 45.15 years STANDARD_DEVIATION 12.74 | 46.04 years STANDARD_DEVIATION 11.91 |
| Sex: Female, Male Female | 58 Participants | 67 Participants | 125 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 73 | 53 / 79 |
| serious Total, serious adverse events | 0 / 73 | 0 / 79 |
Outcome results
Primary
Change in Body Weight
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Body Weight | Baseline (Week 0) | 109.48 kg | Standard Error 2.7 |
| Group A (Exenatide) | Change in Body Weight | Change at Endpoint (Week 24) | -5.06 kg | Standard Error 0.49 |
| Group B (Placebo) | Change in Body Weight | Baseline (Week 0) | 107.64 kg | Standard Error 2.61 |
| Group B (Placebo) | Change in Body Weight | Change at Endpoint (Week 24) | -1.61 kg | Standard Error 0.47 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: <0.0001Mixed Model Repeated Measures ANCOVA
Secondary
Change in Body Mass Index (BMI)
Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Body Mass Index (BMI) | Change at Endpoint (Week 24) | -1.83 kg/m^2 | Standard Error 0.18 |
| Group A (Exenatide) | Change in Body Mass Index (BMI) | Baseline (Week 0) | 39.64 kg/m^2 | Standard Error 0.82 |
| Group B (Placebo) | Change in Body Mass Index (BMI) | Change at Endpoint (Week 24) | -0.58 kg/m^2 | Standard Error 0.17 |
| Group B (Placebo) | Change in Body Mass Index (BMI) | Baseline (Week 0) | 39.39 kg/m^2 | Standard Error 0.79 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: <0.0001Mixed Model Repeated Measures ANCOVA
Secondary
Change in Fasting Serum Glucose
Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Fasting Serum Glucose | Baseline (Week 0) | 5.37 mmol/L | Standard Error 0.07 |
| Group A (Exenatide) | Change in Fasting Serum Glucose | Change at Endpoint (Week 24) | 0.000 mmol/L | Standard Error 0.1 |
| Group B (Placebo) | Change in Fasting Serum Glucose | Baseline (Week 0) | 5.37 mmol/L | Standard Error 0.07 |
| Group B (Placebo) | Change in Fasting Serum Glucose | Change at Endpoint (Week 24) | -0.02 mmol/L | Standard Error 0.1 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.8479Mixed Model Repeated Measures ANCOVA
Secondary
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Glycosylated Hemoglobin (HbA1c) | Change at Endpoint (Week 24) | -0.003 percent | Standard Error 0.04 |
| Group A (Exenatide) | Change in Glycosylated Hemoglobin (HbA1c) | Baseline (Week 0) | 5.61 percent | Standard Error 0.04 |
| Group B (Placebo) | Change in Glycosylated Hemoglobin (HbA1c) | Change at Endpoint (Week 24) | 0.09 percent | Standard Error 0.04 |
| Group B (Placebo) | Change in Glycosylated Hemoglobin (HbA1c) | Baseline (Week 0) | 5.58 percent | Standard Error 0.04 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.0293Mixed Model Repeated Measures ANCOVA
Secondary
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in High Density Lipoprotein (HDL) Cholesterol | Change at Endpoint (Week 24) | 0.004 mmol/L | Standard Error 0.03 |
| Group A (Exenatide) | Change in High Density Lipoprotein (HDL) Cholesterol | Baseline (Week 0) | 1.27 mmol/L | Standard Error 0.04 |
| Group B (Placebo) | Change in High Density Lipoprotein (HDL) Cholesterol | Change at Endpoint (Week 24) | 0.06 mmol/L | Standard Error 0.03 |
| Group B (Placebo) | Change in High Density Lipoprotein (HDL) Cholesterol | Baseline (Week 0) | 1.36 mmol/L | Standard Error 0.04 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.1204ANCOVA
Secondary
Change in High Sensitivity C-reactive Protein (hsCRP)
Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in High Sensitivity C-reactive Protein (hsCRP) | Baseline (Week 0) | 8.61 pmol/L | Standard Error 0.91 |
| Group A (Exenatide) | Change in High Sensitivity C-reactive Protein (hsCRP) | Change at Endpoint (Week 24) | -1.31 pmol/L | Standard Error 0.85 |
| Group B (Placebo) | Change in High Sensitivity C-reactive Protein (hsCRP) | Baseline (Week 0) | 8.03 pmol/L | Standard Error 0.9 |
| Group B (Placebo) | Change in High Sensitivity C-reactive Protein (hsCRP) | Change at Endpoint (Week 24) | -0.44 pmol/L | Standard Error 0.83 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.2919Mixed Model Repeated Measures ANCOVA
Secondary
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Low Density Lipoprotein (LDL) Cholesterol | Baseline (Week 0) | 2.86 mmol/L | Standard Error 0.1 |
| Group A (Exenatide) | Change in Low Density Lipoprotein (LDL) Cholesterol | Change at Endpoint (Week 24) | 0.20 mmol/L | Standard Error 0.09 |
| Group B (Placebo) | Change in Low Density Lipoprotein (LDL) Cholesterol | Baseline (Week 0) | 2.79 mmol/L | Standard Error 0.1 |
| Group B (Placebo) | Change in Low Density Lipoprotein (LDL) Cholesterol | Change at Endpoint (Week 24) | 0.34 mmol/L | Standard Error 0.09 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.1204ANCOVA
Secondary
Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)
Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Baseline (Week 0) | 15.73 (mmol*hr)/L | Standard Error 0.42 |
| Group A (Exenatide) | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Change at Endpoint (Week 24) | -0.47 (mmol*hr)/L | Standard Error 0.37 |
| Group B (Placebo) | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Baseline (Week 0) | 15.19 (mmol*hr)/L | Standard Error 0.42 |
| Group B (Placebo) | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Change at Endpoint (Week 24) | -0.01 (mmol*hr)/L | Standard Error 0.37 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.2151ANCOVA
Secondary
Change in Total Cholesterol
Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Total Cholesterol | Baseline (Week 0) | 4.87 mmol/L | Standard Error 0.11 |
| Group A (Exenatide) | Change in Total Cholesterol | Change at Endpoint (Week 24) | 0.19 mmol/L | Standard Error 0.11 |
| Group B (Placebo) | Change in Total Cholesterol | Baseline (Week 0) | 4.88 mmol/L | Standard Error 0.1 |
| Group B (Placebo) | Change in Total Cholesterol | Change at Endpoint (Week 24) | 0.33 mmol/L | Standard Error 0.11 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.1808ANCOVA
Secondary
Change in Waist-to-hip Ratio
Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (Exenatide) | Change in Waist-to-hip Ratio | Baseline (Week 0) | 0.90 Ratio | Standard Error 0.01 |
| Group A (Exenatide) | Change in Waist-to-hip Ratio | Change at Endpoint (Week 24) | -0.001 Ratio | Standard Error 0.01 |
| Group B (Placebo) | Change in Waist-to-hip Ratio | Baseline (Week 0) | 0.90 Ratio | Standard Error 0.01 |
| Group B (Placebo) | Change in Waist-to-hip Ratio | Change at Endpoint (Week 24) | 0.002 Ratio | Standard Error 0.01 |
Comparison: Analysis pertains to change at endpoint (Week 24)p-value: 0.6766Mixed Model Repeated Measures ANCOVA
Secondary
Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Exenatide) | Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | 13 Participants |
| Group B (Placebo) | Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | 9 Participants |
p-value: 0.2593Cochran-Mantel-Haenszel
Secondary
Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis
Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
Time frame: 24 weeks
Population: Intent to Treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Exenatide) | Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | 3 Participants |
| Group B (Placebo) | Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | 2 Participants |
p-value: 0.6507Cochran-Mantel-Haenszel
Secondary
Percentage of Patients Experiencing >=5% Weight Loss
Percentage of exenatide and placebo treated patients experiencing \>=5% weight loss after 24 weeks of treatment (i.e., \[weight at week 0 minus weight at week 24\] divided by weight at week 0 times 100% \>=5%)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Exenatide) | Percentage of Patients Experiencing >=5% Weight Loss | 31.5 percentage of patients |
| Group B (Placebo) | Percentage of Patients Experiencing >=5% Weight Loss | 16.5 percentage of patients |
p-value: 0.0393Cochran-Mantel-Haenszel
Secondary
Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)
Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Exenatide) | Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | 0.99 Ratio | Standard Error 0.06 |
| Group B (Placebo) | Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | 0.96 Ratio | Standard Error 0.06 |
p-value: 0.6651ANCOVA
Secondary
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)
Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Exenatide) | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) | 1.06 Ratio | Standard Error 0.07 |
| Group B (Placebo) | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) | 1.08 Ratio | Standard Error 0.07 |
p-value: 0.7619ANCOVA
Secondary
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)
Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.
Time frame: 24 weeks
Population: Intent to Treat population; Last Observation Carried Forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A (Exenatide) | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) | 0.92 Ratio | Standard Error 0.08 |
| Group B (Placebo) | Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) | 0.91 Ratio | Standard Error 0.08 |
p-value: 0.8973ANCOVA