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 A/S560 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

560

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinide and metformin combination tabletDRUG

rosiglitazone and metformin combination tabletDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (103)

Outcomes

Primary Outcomes

HbA1c

Time frame: After 26 weeks of treatment

Secondary Outcomes

Change in 8-point Glucose Profiles

Change in Lipid Profile

Events of hypoglycemia

Safety parameters

Change in Fasting Plasma Glucose

Waist/hip ratio change

Change in body weight

Percentage of subjects achieving sudden levels of HbA1c

Data from ClinicalTrials.gov

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