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NCT00568984 Clinical Trial

Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568984
Other study ID # AGEE-3017
Secondary ID
Status Completed
Phase Phase 4
First received December 4, 2007
Last updated February 17, 2017
Start date November 21, 2002
Est. completion date November 10, 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 investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

Recruitment information / eligibility
Status Completed
Enrollment 324
Est. completion date November 10, 2003
Est. primary completion date November 10, 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes for at least 3 months

- No previous treatment for diabetes

- HbA1c between 7.0-12.0%

- Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria:

- Type 1 diabetes

- Known unstable/untreated proliferative retinopathy

- Uncontrolled treated/untreated hypertension

- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide

• metformin

• glicazide

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Tianjin Tianjin
Malaysia Novo Nordisk Investigational Site Cheras
Malaysia Novo Nordisk Investigational Site Ipoh
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Philippines Novo Nordisk Investigational Site Cebu City
Philippines Novo Nordisk Investigational Site Manila
Philippines Novo Nordisk Investigational Site Marikina City
Philippines Novo Nordisk Investigational Site Pampanga
Philippines Novo Nordisk Investigational Site Quezon
Philippines Novo Nordisk Investigational Site Quezon City
Thailand Novo Nordisk Investigational Site Bangkok
Thailand Novo Nordisk Investigational Site Bangkok

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

Countries where clinical trial is conducted

China,  Malaysia,  Philippines,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 16 weeks of treatment
Secondary Glucose profiles
Secondary Quality of life assessment
Secondary Treatment satisfaction
Secondary Hypoglycaemic events
Secondary Adverse events
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