Clinical trial NCT01022762: Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: Week 0, week 16
measure: Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal
timeFrame: Week 0, week 16
measure: Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%
timeFrame: Week 16
measure: Change in Fasting Serum Free Fatty Acid (FFA) From Baseline
timeFrame: Week 0, week 16
measure: Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal
timeFrame: Week 0, week 16
measure: Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)
timeFrame: Over the course of three hours at Week 0 and Week 16
measure: Change in AUC0-180 of Plasma Glucose Concentration of IVGTT
timeFrame: Over the course of three hours at Week 0 and Week 16
measure: Number of All Treatment Emergent Hypoglycaemic Episodes
timeFrame: Weeks 0-16
measure: Cholesterol
timeFrame: Week 0, week 16
measure: Change in Body Weight
timeFrame: Week 0, week 16
Other outcomes:
Locations:
city: Shanghai
country: China
state: Shanghai
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: