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OpenTrials
Completed

NCT Number: NCT02040246

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

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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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repaglinide

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

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.

Primary outcomes

  1. HbA1c change from baseline

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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