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Completed

NCT Number: NCT01022762

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repaglinide

Drug

Individually adjusted dose for 16 weeks

Gliclazide

Drug

Individually adjusted dose for 16 weeks

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Week 0, week 16

Secondary outcomes

  1. Change in Fasting Plasma Glucose

    Time frame: Week 0, week 16

  2. Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal

    Time frame: Week 0, week 16

    A standard meal contains 100g carbohydrate

  3. Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%

    Time frame: Week 16

  4. Change in Fasting Serum Free Fatty Acid (FFA) From Baseline

    Time frame: Week 0, week 16

  5. Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal

    Time frame: Week 0, week 16

  6. 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

  7. Change in AUC0-180 of Plasma Glucose Concentration of IVGTT

    Time frame: Over the course of three hours at Week 0 and Week 16

  8. 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.

  9. 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.

  10. Change in Body Weight

    Time frame: Week 0, week 16

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2009
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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