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Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01103414
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : March 22, 2013
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Mitoglitazone
Drug: Pioglitazone
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Mitoglitazone 50 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet
Mitoglitazone 100 mg Capsules Over-encapsulated Mitoglitazone 100 mg tablet
Mitoglitazone 150 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
Pioglitazone 45 mg Capsules Over-encapsulated ACTOS three 15 mg tablets
Matching Placebo Over-encapsulated placebo tablet

Participant Flow:   Overall Study
    Mitoglitazone 50 mg Capsules   Mitoglitazone 100 mg Capsules   Mitoglitazone 150 mg Capsules   Pioglitazone 45 mg Capsules   Matching Placebo
STARTED   72   71   71   71   71 
COMPLETED   59   62   56   64   56 
NOT COMPLETED   13   9   15   7   15 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized patients who received at least 1 dose of randomized study medication

Reporting Groups
  Description
Mitoglitazone 50 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet
Mitoglitazone 100 mg Capsules Over-encapsulated Mitoglitazone 100 mg tablet
Mitoglitazone 150 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
Pioglitazone 45 mg Capsules Over-encapsulated ACTOS three 15 mg tablets
Matching Placebo Over-encapsulated placebo tablet
Total Total of all reporting groups

Baseline Measures
   Mitoglitazone 50 mg Capsules   Mitoglitazone 100 mg Capsules   Mitoglitazone 150 mg Capsules   Pioglitazone 45 mg Capsules   Matching Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   71   71   71   71   356 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (9.70)   55.5  (10.19)   56.0  (8.76)   54.2  (9.90)   53.4  (8.76)   54.7  (9.47) 
Gender 
[Units: Participants]
           
Female   42   29   26   32   37   166 
Male   30   42   45   39   34   190 
Region of Enrollment 
[Units: Participants]
           
United States   72   71   71   71   71   356 
Fasting plasma glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 176.1  (39.62)   173.7  (36.73)   170.2  (44.22)   172.3  (33.96)   170.2  (43.78)   172.5  (39.70) 
HbA1c 
[Units: Percent]
Mean (Standard Deviation)
 8.2  (0.862)   8.09  (0.816)   8.00  (0.809)   8.08  (0.852)   8.04  (0.845)   8.08  (0.835) 


  Outcome Measures

1.  Primary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in HbA1c   [ Time Frame: 12 weeks ]

3.  Secondary:   Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin   [ Time Frame: 12 weeks ]

4.  Secondary:   Change From Baseline to Week 12 Endpoint in Hematocrit   [ Time Frame: 12 weeks ]

5.  Secondary:   Change From Baseline in Hemoglobin   [ Time Frame: 12 weeks ]

6.  Secondary:   Change From Baseline in RBC   [ Time Frame: 12 week ]

7.  Secondary:   Change in Body Weight From Baseline to Week 12 Endpoint   [ Time Frame: 12 weeks ]

8.  Secondary:   Change From Baseline in Waist Circumference at Week 12 Endpoint   [ Time Frame: 12 weeks ]

9.  Secondary:   Presence of Edema Post Baseline During 12 Weeks Active Treatment   [ Time Frame: 12 weeks ]

10.  Secondary:   Changes in HDL Particle Size Subfractions From Baseline to Week 12   [ Time Frame: 12 weeks ]

11.  Secondary:   Changes in LDL Particle Size Subfractions From Baseline to Week 12   [ Time Frame: 12 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jerry Colca, President & CSO
Organization: Mstabolic Solutions Company. LLC
phone: 269.343.6732
e-mail: jcolca@msdrx.com



Responsible Party: Metabolic Solutions Development Company
ClinicalTrials.gov Identifier: NCT01103414     History of Changes
Other Study ID Numbers: MSDC-C004
First Submitted: April 7, 2010
First Posted: April 14, 2010
Results First Submitted: February 15, 2013
Results First Posted: March 22, 2013
Last Update Posted: April 28, 2015