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NCT01720290 Clinical Trial

Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A 3-month, Open-label, Randomized, Multi-center Study of Repaglinide in Combination With Metformin as Compared to Metformin or Repaglinide Given as Monotherapy for the Treatment of Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01720290
Other study ID # AGEE-3018
Secondary ID
Status Completed
Phase Phase 4
First received October 31, 2012
Last updated February 17, 2017
Start date July 25, 2002
Est. completion date February 25, 2003

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date February 25, 2003
Est. primary completion date February 25, 2003
Accepts healthy volunteers No
Gender All
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria:

- Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)

- Body Mass Index (BMI) of 21-35 kg/m^2

- HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion Criteria:

- Treatment with insulin within the last 3 months preceding the trial

- Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)

- Participation in any other clinical trial within 30 days of screening

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide
Dose individually adjusted
• metformin
Dose individually adjusted
• metformin
Dose at 1000 mg/day

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing
China Novo Nordisk Investigational Site Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c (glycosylated haemoglobin A1c)
Secondary Fasting blood glucose (FBG)
Secondary 1-hour post prandial blood glucose (PPBG)
Secondary Incidence of hypoglycemic episodes
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