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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01022762
First received: November 26, 2009
Last updated: June 25, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]
  • Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Fasting Serum Free Fatty Acid (FFA) From Baseline [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]
  • Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in AUC0-180 of Plasma Glucose Concentration of IVGTT [ Time Frame: Over the course of three hours at Week 0 and Week 16 ] [ Designated as safety issue: No ]
  • Number of All Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Weeks 0-16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01022762     History of Changes
Other Study ID Numbers: AGEE-3783, U1111-1111-9453
Study First Received: November 26, 2009
Results First Received: November 24, 2011
Last Updated: June 25, 2014
Health Authority: China: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014