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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Repaglinide Drug: Metformin
Phase	Phase 4
Sponsor	RenJi Hospital
Responsible Party	RenJi Hospital
ClinicalTrials.gov Identifier	NCT02040246
First Received	December 25, 2013
Last Updated	January 16, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 25, 2013
Last Updated Date	January 16, 2014
Start Date	February 2009
Estimated Primary Completion Date	January 2014
Current Primary Outcome Measures	HbA1c change from baseline [Time Frame: week 12] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
Official Title	Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
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 Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: 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. 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.
Study Arm (s)	Experimental: 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. Active Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	107
Estimated Completion Date	January 2014
Estimated Primary Completion Date	December 2013
Eligibility Criteria	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.
Gender	Both
Ages	40 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT02040246
Other Study ID Numbers	NSFC-81070651
Has Data Monitoring Committee	Yes
Information Provided By	RenJi Hospital
Study Sponsor	RenJi Hospital
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	January 2014

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