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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing Ma, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT02040246
First received: December 25, 2013
Last updated: January 16, 2014
Last verified: January 2014

December 25, 2013
January 16, 2014
February 2009
December 2013   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02040246 on ClinicalTrials.gov Archive Site
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Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China
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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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • 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.
    Intervention: Drug: Repaglinide
  • 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.
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT02040246
NSFC-81070651
Yes
Jing Ma, RenJi Hospital
RenJi Hospital
Not Provided
Not Provided
RenJi Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP