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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00399711

Enrollment

560

Registered

2006-11-15

Start date

2006-11-30

Completion date

2007-11-30

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGrepaglinide and metformin combination tablet

DRUGrosiglitazone and metformin combination tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
HbA1c	After 26 weeks of treatment

Secondary

Measure	Time frame
Change in Lipid Profile	—
Events of hypoglycemia	—
Safety parameters	—
Change in 8-point Glucose Profiles	—
Waist/hip ratio change	—
Change in body weight	—
Percentage of subjects achieving sudden levels of HbA1c	—
Change in Fasting Plasma Glucose	—

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026