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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
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: gliclazide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 16 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 440
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: repaglinide
Individually adjusted dose for 16 weeks
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
Drug: gliclazide
Individually adjusted dose for 16 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022762


Locations
China, Shanghai
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01022762     History of Changes
Other Study ID Numbers: AGEE-3783
U1111-1111-9453 ( Other Identifier: WHO )
First Submitted: November 26, 2009
First Posted: December 1, 2009
Results First Submitted: November 24, 2011
Results First Posted: December 29, 2011
Last Update Posted: July 9, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Hypoglycemic Agents
Gliclazide
Physiological Effects of Drugs