NCT00399711CompletedPhase 3
Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 560
- Locations
- 104
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes for at least 3 months
- •HbA1c between 7.5-11.0% on monotherapy or
- •HbA1c between 7.0-10.0% on dual therapy
- •BMI maximum 45 kg/m2
Exclusion Criteria
- •Any clinically significant disease history in the opinion of the investigator
- •Severe heart disease
- •Pregnancy
Outcomes
Primary Outcomes
HbA1c
Time Frame: After 26 weeks of treatment
Secondary Outcomes
- Change in Lipid Profile
- Events of hypoglycemia
- Change in 8-point Glucose Profiles
- Safety parameters
- Change in Fasting Plasma Glucose
- Waist/hip ratio change
- Change in body weight
- Percentage of subjects achieving sudden levels of HbA1c
Investigators
Study Sites (104)
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