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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00399711
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	After 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇷 San Juan, Puerto Rico