A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 367
- Locations
- 2
- Primary Endpoint
- change from baseline in HbA1c
Study Overview
Brief Summary
The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 2 diabetes diagnosed for at least 6 months
- •stable metformin usage for at least 4 months
- •HbA1c 7.5% - 10.5% inclusive
- •no severe diabetic complications
Exclusion Criteria
- •chronic insulin use
- •use of oral diabetic agent within 12 weeks
- •acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
Arms & Interventions
1
metformin + placebo for mitiglinide
Intervention: placebo for mitiglinide (Drug)
2
metformin + mitiglinide three times a day with meals
Intervention: mitiglinide (Drug)
3
metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
Intervention: mitiglinide (Drug)
Outcomes
Primary Outcomes
change from baseline in HbA1c
Time Frame: after 24 weeks of treatment
Secondary Outcomes
- change from baseline in 2-hour post-prandial glucose(after 24 weeks of treatment)
- change from baseline in fasting plasma glucose(after 24 weeks of treatment)