Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
Phase 2B, Randomized, Double-Blind, Comparator- & Placebo-Controlled, Dose Ranging Study to Evaluate Safety, Tolerability & Efficacy of 3 Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
1 other identifier
interventional
356
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Sep 2010
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 14, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 22, 2013
CompletedApril 28, 2015
April 1, 2013
1.2 years
April 7, 2010
February 15, 2013
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 12
Secondary Outcomes (10)
Change From Baseline in HbA1c
12 weeks
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin
12 weeks
Change From Baseline to Week 12 Endpoint in Hematocrit
12 weeks
Change From Baseline in Hemoglobin
12 weeks
Change From Baseline in RBC
12 week
- +5 more secondary outcomes
Study Arms (5)
Mitoglitazone 50 mg capsules
EXPERIMENTALMitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone 100 mg capsules
EXPERIMENTALMitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone 150 mg capsules
EXPERIMENTALMitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Pioglitazone 45 mg capsules
ACTIVE COMPARATORPioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Matching placebo
PLACEBO COMPARATORPlacebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Interventions
50 mg capsules, once daily for 84 days
Pioglitazone 45 mg, once daily for 84 days
Eligibility Criteria
You may qualify if:
- 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).
- Between the ages of 18-75 years, inclusive.
- 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.
- Body Mass Index (BMI) = 23 kg/m2 to 45 kg/m2 (inclusive).
- Willing and able to make a screening visit to the clinic and seven visits over a 21 week period.
- 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.
You may not qualify if:
- Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Fasting plasma glucose in excess of 240 mg/dl at screening
- 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.
- 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.
- History nephropathy, neuropathy, or retinopathy within 6 months of screening.
- Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization.
- Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
- Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study.
- Febrile illness within the 5 days prior to the first dose.
- Known history of HIV, hepatitis B, or hepatitis C.
- Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG.
- 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.
- 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.
- Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Chino, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richley, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Tiffin, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Eugene, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jerry Colca, President & CSO
- Organization
- Mstabolic Solutions Company. LLC
Study Officials
- STUDY DIRECTOR
Jerry R Colca, PhD
MSDC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2010
First Posted
April 14, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
April 28, 2015
Results First Posted
March 22, 2013
Record last verified: 2013-04