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Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022762
First Posted: December 1, 2009
Last Update Posted: July 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
November 26, 2009
December 1, 2009
November 24, 2011
December 29, 2011
July 9, 2014
November 2009
November 2010   (Final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 16 ]
HbA1c change from baseline [ Time Frame: after 16 weeks of treatment ]
Complete list of historical versions of study NCT01022762 on ClinicalTrials.gov Archive Site
  • Change in Fasting Plasma Glucose [ Time Frame: Week 0, week 16 ]
  • Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal [ Time Frame: Week 0, week 16 ]
    A standard meal contains 100g carbohydrate
  • Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5% [ Time Frame: Week 16 ]
  • Change in Fasting Serum Free Fatty Acid (FFA) From Baseline [ Time Frame: Week 0, week 16 ]
  • Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal [ Time Frame: Week 0, week 16 ]
  • Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test) [ Time Frame: Over the course of three hours at Week 0 and Week 16 ]
  • Change in AUC0-180 of Plasma Glucose Concentration of IVGTT [ Time Frame: Over the course of three hours at Week 0 and Week 16 ]
  • Number of All Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Weeks 0-16 ]
    A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.
  • Cholesterol [ Time Frame: Week 0, week 16 ]
    The number of participants having a change in cholesterol from "normal" to "abnormal". "Abnormal" means a value of blood cholesterol is out of the normal range.
  • Change in Body Weight [ Time Frame: Week 0, week 16 ]
  • Fasting glucose change from baseline [ Time Frame: after 16 weeks of treatment ]
  • 2-hour postprandial plasma glucose change from baseline [ Time Frame: after 16 weeks of treatment ]
  • Percentage of subjects achieving HbA1c below or equal to 6.5% from baseline [ Time Frame: after 16 weeks of treatment ]
  • Fasting serum FFA change from baseline [ Time Frame: after 16 weeks of treatment ]
  • 2-hour postprandial serum FFA change from baseline [ Time Frame: after 16 weeks of treatment ]
  • Change of serum insulin profile and plasma glucose excursions measured by IVGTT parameters from baseline [ Time Frame: after 16 weeks of treatment ]
  • Hypoglycaemic episodes [ Time Frame: over 16 weeks of treatment ]
  • Fasting blood lipid profile change from baseline [ Time Frame: after 16 weeks of treatment ]
  • Body weight change from baseline [ Time Frame: after 16 weeks of treatment ]
Not Provided
Not Provided
 
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
A 16-week, Multicentre, Randomised, Open-label, Parallel Group Study to Investigate the Efficacy and Safety Profiles of Repaglinide Monotherapy Compared to Gliclazide Monotherapy in Chinese Antidiabetic-naïve Subjects With Type 2 Diabetes
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: repaglinide
    Individually adjusted dose for 16 weeks
  • Drug: gliclazide
    Individually adjusted dose for 16 weeks
  • Active Comparator: repaglinide
    1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
    Intervention: Drug: repaglinide
  • Active Comparator: gliclazide
    80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
    Intervention: Drug: gliclazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
  • Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
  • Lipid-lowing agent naïve
  • HbA1c: 6.5-8.5%
  • Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
  • Body Mass Index (BMI): 20-35 kg/m^2
  • Be able and willing to perform self-monitored plasma glucose (SMPG)
  • Be able and willing to eat 3 main meals per day
  • Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion Criteria:

  • Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
  • Previous participation in this study
  • Participation in a study of another investigational drug within 1 month prior to study start
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01022762
AGEE-3783
U1111-1111-9453 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

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