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NCT01103414 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Type 2 Diabetes, sponsored by Metabolic Solutions Development Company.

Completed
Registry status
Phase 2
Development phase
356
Enrollment target
20
Study locations

NCT01103414: Completed Phase 2 study of Type 2 Diabetes, sponsored by Metabolic Solutions Development Company.

NCT01103414 is a Phase 2 study of Type 2 Diabetes that has completed, run by Metabolic Solutions Development Company. The registered enrollment target is 356 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01103414, a Phase 2 study of Type 2 Diabetes, has completed, sponsored by Metabolic Solutions Development Company.

COMPLETED
Registry status
Phase 2
Development phase
356 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Pioglitazone
  • DRUG Mitoglitazone

Study Locations (20)

California

  • - Chino
  • - Los Angeles
  • - Spring Valley
  • - Walnut Creek

Florida

  • - Miami
  • - New Port Richley
  • - Palm Harbor
  • - Pembroke Pines

Ohio

  • - Cincinnati
  • - Kettering
  • - Tiffin

Alabama

  • - Huntsville
  • - Muscle Shoals

Oregon

  • - Eugene
  • - Portland

Georgia

  • - Marietta

Illinois

  • - Chicago

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 356 participants
Start Date 2010-09
Est. Completion 2011-12
Phase Phase 2

What the finished NCT01103414 record still lists

NCT01103414 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01103414 names 20 study sites across 10 states, led by California, Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT01103414 about?

NCT01103414 is a clinical study titled "Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients". 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.

What is the current status of trial NCT01103414?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2010-09. Estimated completion is 2011-12.

What conditions does trial NCT01103414 study?

This clinical trial studies the following conditions: Type 2 Diabetes.

What interventions are being tested in trial NCT01103414?

The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG), Mitoglitazone (DRUG).

Who is sponsoring clinical trial NCT01103414?

This trial is sponsored by Metabolic Solutions Development Company, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01103414 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01103414's enrollment target sits among peer trials

356 56th of 327 higher than 272 of 327 other Type 2 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01103414, the US trial registry maintained by the National Library of Medicine. NCT01103414 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.