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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Repaglinide

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No