Phase 3
Completed N=99
Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01072331 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) — -56.2; -43.7; -5.5; -43.1 mg / dL
Summary
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) |
-56.2; -43.7; -5.5; -43.1; -36.9; -8.3 | — |
| PRIMARY Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) |
-82.114; -75.437; -8.950; -92.947; -86.843; -6.884 | — |
| SECONDARY Change From Baseline in 24-h Mean Glucose |
-34.722; -30.921; -5.402 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-20.7; -20.5; -6.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are 20 - 75 years old
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
- Patients whose HbA1c is ≥6.5% and <10.0%
- Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.
Exclusion Criteria
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients who are accepting treatments of arrhythmias
- Patients with serious diabetic complications
- Patients who are the excessive alcohol addicts
- Patients with severe hepatic disorder or severe renal disorder.
- Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT01072331). 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.