Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGplacebo for mitiglinide
three times a day with meals
DRUGmitiglinide
three times a day with meals
Sponsors
Elixir Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in HbA1c | after 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Puerto Rico, United States
Outcome results
None listed