Type 2 Diabetes
Conditions
Keywords
Diabetes
Brief summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.
Detailed description
The primary study objectives are to characterize the reduction in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes and to investigate the safety and tolerability of three different doses of Mitoglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Interventions
DRUGMitoglitazone
50 mg capsules, once daily for 84 days
DRUGPioglitazone
Pioglitazone 45 mg, once daily for 84 days
DRUGPlacebo
Placebo, once daily for 84 days
Sponsors
Metabolic Solutions Development Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females with Type 2 diabetes (fasting plasma glucose ≥126 mg/dL at screening, glycosylated hemoglobin \[HbA1c\] \>7 and ≤10%, and Insulin C-peptide \>1 ng/mL). Patients can be naïve to diabetes therapy or if taking metformin should be on a stable dose level for a period of at least 3 months prior to screening visit (no dose limit). 2. Between the ages of 18-75 years, inclusive. 3. Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Menopausal status will be verified by a follicle-stimulating hormone (FSH) test. If FSH levels are below 40 mIL/mL, some method of birth control must be used. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screen and Day 15 regardless of childbearing potential. Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse. 4. Body Mass Index (BMI) = 23 kg/m2 to 45 kg/m2 (inclusive). 5. Willing and able to make a screening visit to the clinic and seven visits over a 21 week period. 6. Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
Exclusion criteria
1. Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening. 2. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 3. Fasting plasma glucose in excess of 240 mg/dl at screening 4. History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening. 5. ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine \>1.5 mg/dL in men or \> 1.4 mg/dL in women. 6. History nephropathy, neuropathy, or retinopathy within 6 months of screening. 7. Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization. 8. Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments. 9. Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study. 10. Febrile illness within the 5 days prior to the first dose. 11. Known history of HIV, hepatitis B, or hepatitis C. 12. Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. 13. Blood pressure greater than 160/100 mmHg. Patients with elevated BP (\<160/100 mmHg) with or without current treatment will be allowed at the discretion of the Principal Investigator (PI) and primary care physician. Individuals with hypertension must have been stabilized to the current treatment regimen for at least 6 weeks prior to screening. 14. Change in BP or lipid-lowering medication within 6 weeks or change in dose of metformin or thyroid replacement within 3 months prior to screening. 15. Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients. 16. History of alcohol or drug abuse within 6 months of Screening. 17. Have participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration. 18. Blood donation of 1 pint or more within 56 days of screening. 19. Plasmapheresis or plasma donation within 30 days of screening. 20. Single 12-lead ECG demonstrating a QTc \>450 msec at Screening. A single repeat ECG may be done at the investigator's discretion. 21. Any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome. 22. Evidence of clinically relevant pathology that could interfere with the study results or put the patient's safety at risk. 23. Malignancy, including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | Baseline, Week 12 | Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c | 12 weeks | Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes. |
| Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 12 weeks | Percent change from baseline to week 12 endpoint in high molecular weight adiponectin |
| Change From Baseline to Week 12 Endpoint in Hematocrit | 12 weeks | Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention |
| Change From Baseline in Hemoglobin | 12 weeks | Change from baseline at week 12 endpoint in hemoglobin concentration |
| Change From Baseline in RBC | 12 week | Change from baseline at week 12 endpoint in red blood cell concentration |
| Change in Body Weight From Baseline to Week 12 Endpoint | 12 weeks | Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12 |
| Change From Baseline in Waist Circumference at Week 12 Endpoint | 12 weeks | Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks |
| Presence of Edema Post Baseline During 12 Weeks Active Treatment | 12 weeks | Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks |
| Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 12 weeks | Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks |
| Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 12 week | Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 26 investigational sites in the United States. Over the course of the study, 786 patients were screened, 356 patients were randomized, 297 patients completed the study, and 258 patients completed the study for the Modified Per Protocol Population which required compliance with taking the active medications.
Pre-assignment details
The study consisted of a 14-day, placebo lead-in period & an 84-day double-blind treatment period. At screening, patients were required to have FPG ≥126 mg/dL, HbA1c 7-10%, and insulin C-peptide \>1 ng/mL. At the end of the lead-in period, eligible patients were randomized based on a stratification criterion of current metformin use (yes, no).
Participants by arm
| Arm | Count |
|---|---|
| Mitoglitazone 50 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet | 72 |
| Mitoglitazone 100 mg Capsules Over-encapsulated Mitoglitazone 100 mg tablet | 71 |
| Mitoglitazone 150 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet | 71 |
| Pioglitazone 45 mg Capsules Over-encapsulated ACTOS three 15 mg tablets | 71 |
| Matching Placebo Over-encapsulated placebo tablet | 71 |
| Total | 356 |
Baseline characteristics
| Characteristic | Mitoglitazone 50 mg Capsules | Mitoglitazone 100 mg Capsules | Mitoglitazone 150 mg Capsules | Pioglitazone 45 mg Capsules | Matching Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 9.7 | 55.5 years STANDARD_DEVIATION 10.19 | 56.0 years STANDARD_DEVIATION 8.76 | 54.2 years STANDARD_DEVIATION 9.9 | 53.4 years STANDARD_DEVIATION 8.76 | 54.7 years STANDARD_DEVIATION 9.47 |
| Fasting plasma glucose | 176.1 mg/dL STANDARD_DEVIATION 39.62 | 173.7 mg/dL STANDARD_DEVIATION 36.73 | 170.2 mg/dL STANDARD_DEVIATION 44.22 | 172.3 mg/dL STANDARD_DEVIATION 33.96 | 170.2 mg/dL STANDARD_DEVIATION 43.78 | 172.5 mg/dL STANDARD_DEVIATION 39.7 |
| HbA1c | 8.2 percent STANDARD_DEVIATION 0.862 | 8.09 percent STANDARD_DEVIATION 0.816 | 8.00 percent STANDARD_DEVIATION 0.809 | 8.08 percent STANDARD_DEVIATION 0.852 | 8.04 percent STANDARD_DEVIATION 0.845 | 8.08 percent STANDARD_DEVIATION 0.835 |
| Region of Enrollment United States | 72 participants | 71 participants | 71 participants | 71 participants | 71 participants | 356 participants |
| Sex: Female, Male Female | 42 Participants | 29 Participants | 26 Participants | 32 Participants | 37 Participants | 166 Participants |
| Sex: Female, Male Male | 30 Participants | 42 Participants | 45 Participants | 39 Participants | 34 Participants | 190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 71 | 5 / 71 | 5 / 70 | 6 / 71 | 6 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 | 1 / 70 | 3 / 71 | 0 / 71 |
Outcome results
Primary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.
Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Time frame: Baseline, Week 12
Population: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | -5.3 mg/dL | Standard Error 4.95 |
| Mitoglitazone 100 mg Capsules | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | -14.6 mg/dL | Standard Error 4.74 |
| Mitoglitazone 150 mg Capsules | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | -25.1 mg/dL | Standard Error 4.99 |
| Pioglitazone 45 mg Capsules | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | -27.2 mg/dL | Standard Error 4.61 |
| Matching Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. | 3.8 mg/dL | Standard Error 4.59 |
p-value: 0.181995% CI: [-22.4, 4.3]ANCOVA
p-value: 0.005795% CI: [-31.4, -5.4]ANCOVA
p-value: <0.000195% CI: [-42.3, -15.6]ANCOVA
p-value: <0.000195% CI: [-43.8, -18.2]ANCOVA
Secondary
Change From Baseline in HbA1c
Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Time frame: 12 weeks
Population: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline in HbA1c | -0.10 percentage of hemoglobin | Standard Deviation 0.129 |
| Mitoglitazone 100 mg Capsules | Change From Baseline in HbA1c | -0.49 percentage of hemoglobin | Standard Deviation 0.123 |
| Mitoglitazone 150 mg Capsules | Change From Baseline in HbA1c | -0.57 percentage of hemoglobin | Standard Deviation 0.13 |
| Pioglitazone 45 mg Capsules | Change From Baseline in HbA1c | -0.69 percentage of hemoglobin | Standard Deviation 0.12 |
| Matching Placebo | Change From Baseline in HbA1c | 0.29 percentage of hemoglobin | Standard Deviation 0.119 |
p-value: 0.027395% CI: [-0.73, -0.04]ANCOVA
p-value: <0.000195% CI: [-1.13, -0.45]ANCOVA
p-value: <0.000195% CI: [-1.21, -0.52]ANCOVA
p-value: <0.000195% CI: [-1.32, -0.65]ANCOVA
Secondary
Change From Baseline in Hemoglobin
Change from baseline at week 12 endpoint in hemoglobin concentration
Time frame: 12 weeks
Population: All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline in Hemoglobin | -0.07 g/dL | Standard Deviation 0.729 |
| Mitoglitazone 100 mg Capsules | Change From Baseline in Hemoglobin | -0.38 g/dL | Standard Deviation 0.72 |
| Mitoglitazone 150 mg Capsules | Change From Baseline in Hemoglobin | -0.33 g/dL | Standard Deviation 0.676 |
| Pioglitazone 45 mg Capsules | Change From Baseline in Hemoglobin | -0.60 g/dL | Standard Deviation 0.827 |
| Matching Placebo | Change From Baseline in Hemoglobin | -0.07 g/dL | Standard Deviation 0.67 |
Secondary
Change From Baseline in RBC
Change from baseline at week 12 endpoint in red blood cell concentration
Time frame: 12 week
Population: All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline in RBC | -0.014 10e-6 cells per uL | Standard Deviation 0.2073 |
| Mitoglitazone 100 mg Capsules | Change From Baseline in RBC | -0.098 10e-6 cells per uL | Standard Deviation 0.2332 |
| Mitoglitazone 150 mg Capsules | Change From Baseline in RBC | -0.107 10e-6 cells per uL | Standard Deviation 0.2499 |
| Pioglitazone 45 mg Capsules | Change From Baseline in RBC | -0.211 10e-6 cells per uL | Standard Deviation 0.2878 |
| Matching Placebo | Change From Baseline in RBC | 0.035 10e-6 cells per uL | Standard Deviation 0.248 |
Secondary
Change From Baseline in Waist Circumference at Week 12 Endpoint
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks
Time frame: 12 weeks
Population: All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline in Waist Circumference at Week 12 Endpoint | 0.1 cm | Standard Deviation 3.39 |
| Mitoglitazone 100 mg Capsules | Change From Baseline in Waist Circumference at Week 12 Endpoint | -0.2 cm | Standard Deviation 2.13 |
| Mitoglitazone 150 mg Capsules | Change From Baseline in Waist Circumference at Week 12 Endpoint | -0.4 cm | Standard Deviation 4.02 |
| Pioglitazone 45 mg Capsules | Change From Baseline in Waist Circumference at Week 12 Endpoint | 0.7 cm | Standard Deviation 2.95 |
| Matching Placebo | Change From Baseline in Waist Circumference at Week 12 Endpoint | -0.9 cm | Standard Deviation 3.21 |
Secondary
Change From Baseline to Week 12 Endpoint in Hematocrit
Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention
Time frame: 12 weeks
Population: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change From Baseline to Week 12 Endpoint in Hematocrit | 0.0 percentage of volume | Standard Error 0.34 |
| Mitoglitazone 100 mg Capsules | Change From Baseline to Week 12 Endpoint in Hematocrit | -0.9 percentage of volume | Standard Error 0.33 |
| Mitoglitazone 150 mg Capsules | Change From Baseline to Week 12 Endpoint in Hematocrit | -1.0 percentage of volume | Standard Error 0.34 |
| Pioglitazone 45 mg Capsules | Change From Baseline to Week 12 Endpoint in Hematocrit | -1.7 percentage of volume | Standard Error 0.32 |
| Matching Placebo | Change From Baseline to Week 12 Endpoint in Hematocrit | 0.0 percentage of volume | Standard Error 0.32 |
Secondary
Change in Body Weight From Baseline to Week 12 Endpoint
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12
Time frame: 12 weeks
Population: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Change in Body Weight From Baseline to Week 12 Endpoint | 0.23 kg | Standard Deviation 0.318 |
| Mitoglitazone 100 mg Capsules | Change in Body Weight From Baseline to Week 12 Endpoint | 0.56 kg | Standard Deviation 0.306 |
| Mitoglitazone 150 mg Capsules | Change in Body Weight From Baseline to Week 12 Endpoint | 1.15 kg | Standard Deviation 0.323 |
| Pioglitazone 45 mg Capsules | Change in Body Weight From Baseline to Week 12 Endpoint | 1.53 kg | Standard Deviation 0.297 |
| Matching Placebo | Change in Body Weight From Baseline to Week 12 Endpoint | -0.71 kg | Standard Deviation 0.294 |
Secondary
Changes in HDL Particle Size Subfractions From Baseline to Week 12
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks
Time frame: 12 weeks
Population: The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 0.00 nM | Standard Deviation 0.25 |
| Mitoglitazone 100 mg Capsules | Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 0.05 nM | Standard Deviation 0.4 |
| Mitoglitazone 150 mg Capsules | Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 0.10 nM | Standard Deviation 0.3 |
| Pioglitazone 45 mg Capsules | Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 0.20 nM | Standard Deviation 0.5 |
| Matching Placebo | Changes in HDL Particle Size Subfractions From Baseline to Week 12 | 0.00 nM | Standard Deviation 0.25 |
Secondary
Changes in LDL Particle Size Subfractions From Baseline to Week 12
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks
Time frame: 12 week
Population: The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 0.20 nM | Standard Deviation 0.6 |
| Mitoglitazone 100 mg Capsules | Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 0.20 nM | Standard Deviation 0.55 |
| Mitoglitazone 150 mg Capsules | Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 0.30 nM | Standard Deviation 0.5 |
| Pioglitazone 45 mg Capsules | Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 0.60 nM | Standard Deviation 0.7 |
| Matching Placebo | Changes in LDL Particle Size Subfractions From Baseline to Week 12 | 0.00 nM | Standard Deviation 0.4 |
Secondary
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin
Percent change from baseline to week 12 endpoint in high molecular weight adiponectin
Time frame: 12 weeks
Population: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mitoglitazone 50 mg Capsules | Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 45.2 percentage of baseline values | Standard Deviation 18.15 |
| Mitoglitazone 100 mg Capsules | Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 94.4 percentage of baseline values | Standard Deviation 17.44 |
| Mitoglitazone 150 mg Capsules | Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 132.4 percentage of baseline values | Standard Deviation 18.34 |
| Pioglitazone 45 mg Capsules | Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 287.0 percentage of baseline values | Standard Deviation 16.94 |
| Matching Placebo | Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin | 4.9 percentage of baseline values | Standard Deviation 16.82 |
Secondary
Presence of Edema Post Baseline During 12 Weeks Active Treatment
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks
Time frame: 12 weeks
Population: All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitoglitazone 50 mg Capsules | Presence of Edema Post Baseline During 12 Weeks Active Treatment | 8 participants |
| Mitoglitazone 100 mg Capsules | Presence of Edema Post Baseline During 12 Weeks Active Treatment | 9 participants |
| Mitoglitazone 150 mg Capsules | Presence of Edema Post Baseline During 12 Weeks Active Treatment | 4 participants |
| Pioglitazone 45 mg Capsules | Presence of Edema Post Baseline During 12 Weeks Active Treatment | 6 participants |
| Matching Placebo | Presence of Edema Post Baseline During 12 Weeks Active Treatment | 8 participants |