Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Repaglinide; Drug: Metformin

• Registration Number: NCT02040246
• Lead Sponsor: RenJi Hospital

Brief Summary

The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well controlled.Among all kinds of antidiabetic medications, metformin is recommended as the first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide is still one of the most widely used antidiabetic medications in China. However, there were few studies comparing the effects of these two medications on glycaemic control in Chinese patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2013-12
• Study First Submitted: 2013-12-25
• Status Verified: 2014-01
• Study Completion: 2014-01
• Study First Submitted QC: 2014-01-16
• Last Update Submitted: 2014-01-16
• Study First Posted: 2014-01-20
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital

Exclusion Criteria

• Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repaglinide	Repaglinide	Initial dose of repaglinide 0.5 mg once daily. During the dose titration period of 1 week, the dose of repaglinide could be titrated up to 1 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 0.5 mg three times daily.
Metformin	Metformin	Initial dose of metformin 250mg once daily. During the dose titration period of 1 week, the dose could be titrated up to metformin 500 mg three times daily, according to fasting glucose values.

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline	week 12

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China