Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
NCT ID: NCT01103414
Last Updated: 2015-04-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
356 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
NCT00760578
A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients
NCT01280695
Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes
NCT00772174
Effects of Insulin Sensitizers in Subjects With Impaired Glucose Tolerance
NCT00108615
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
NCT05721729
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mitoglitazone 50 mg capsules
Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone
50 mg capsules, once daily for 84 days
Mitoglitazone 100 mg capsules
Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone
Mitoglitazone 100 mg capsules, once daily for 84 days
Mitoglitazone 150 mg capsules
Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone
Mitoglitazone 150 mg capsules, once daily for 84 days
Pioglitazone 45 mg capsules
Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Pioglitazone
Pioglitazone 45 mg, once daily for 84 days
Matching placebo
Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Placebo
Placebo, once daily for 84 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mitoglitazone
50 mg capsules, once daily for 84 days
Mitoglitazone
Mitoglitazone 100 mg capsules, once daily for 84 days
Mitoglitazone
Mitoglitazone 150 mg capsules, once daily for 84 days
Pioglitazone
Pioglitazone 45 mg, once daily for 84 days
Placebo
Placebo, once daily for 84 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Metabolic Solutions Development Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jerry R Colca, PhD
Role: STUDY_DIRECTOR
MSDC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Chino, California, United States
Los Angeles, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Miami, Florida, United States
New Port Richley, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Grand Rapids, Michigan, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Tiffin, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Greer, South Carolina, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MSDC-C004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.