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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Repaglinide; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02040246

NSFC-81070651

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Repaglinide

Experimental group

Description:

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.

Treatment:

Drug: Repaglinide

Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin