Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: rosiglitazone and metformin combination tablet; Drug: repaglinide and metformin combination tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399711

NN4440-1794

Details and patient eligibility

About

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.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)