Phase 2
Completed N=86
A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
Source: ClinicalTrials.gov NCT00760578 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test — 0.16; -0.44; -1.10; 0.51 mmol/L
Summary
The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test |
0.16; -0.44; -1.10; 0.51 | — |
| SECONDARY Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test |
0.74; -9.77; -12.24; -1.60 | — |
| SECONDARY Change From Baseline in FFAs |
-0.05; -0.15; -0.19; -0.01 | — |
| SECONDARY Change From Baseline in Triglycerides |
0.12; -0.21; -0.49; 0.15 | — |
| SECONDARY Change From Baseline in HDL |
0.00; 0.11; 0.09; -0.03 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Type 2 Diabetes naive or on metformin
- Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.
Exclusion Criteria
- Use of diabetes medications other than metformin.
- History of heart failure or previous myocardial infarction.
- Blood pressure great than 160/100 mmHg.
Data sourced from ClinicalTrials.gov (NCT00760578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.