Phase 4
Completed N=440
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
Source: ClinicalTrials.gov NCT01022762 ↗Enrolled (actual)
440
Serious AEs
0.7%
Results posted
Dec 2011
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -0.857; -0.871 percentage (%) of total haemoglobin
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.857; -0.871 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-1.409; -1.667 | — |
| SECONDARY Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal |
-0.596; -0.699 | — |
| SECONDARY Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5% |
62; 59 | — |
| SECONDARY Change in Fasting Serum Free Fatty Acid (FFA) From Baseline |
-0.012; -0.02 | — |
| SECONDARY Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal |
-0.003; -0.004 | — |
| SECONDARY Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test) |
5139.55; 1426.21 | — |
| SECONDARY Change in AUC0-180 of Plasma Glucose Concentration of IVGTT |
-272.30; -348.03 | — |
| SECONDARY Number of All Treatment Emergent Hypoglycaemic Episodes |
165; 147 | — |
| SECONDARY Cholesterol |
18; 11 | — |
| SECONDARY Change in Body Weight |
-0.750; -0.511 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01022762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.