Phase 2
N=183
Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00497198 ↗Enrolled (actual)
183
Serious AEs
3.3%
Results posted
Aug 2011
Primary outcome: Primary: Fasting Plasma Glucose at Baseline — 170.2; 168.2 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MCI-196 (Drug); Placebo of MCI-196 Tablet (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Plasma Glucose at Baseline |
170.2; 168.2 | — |
| PRIMARY Change From Baseline in Blood Glucose at Week 12 |
-21.3; 0.8 | — |
| PRIMARY Hemoglobin A1c (HbA1c) at Baseline |
7.97; 7.94 | — |
| PRIMARY Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 |
-0.70; 0.18 | — |
| SECONDARY Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 |
-28.9; -0.2 | — |
Summary
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.
Eligibility Criteria
Inclusion Criteria
- Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
- Patients whose HbA1c is 7.0% or above during the observation period.
Exclusion Criteria
- Patients with serious cardiac, hepatic or renal complications.
- Patients with serious diabetic complications.
- Patients with complete biliary obstruction or ileus.
- Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.
Data sourced from ClinicalTrials.gov (NCT00497198). 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.