Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01022762
First received: November 26, 2009
Last updated: February 3, 2012
Last verified: February 2012
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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:
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, 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: | February 3, 2012 |
| 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 Gliclazide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013