Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2760
Source ID: NCT01022762
Associated Drug: Repaglinide
Title: Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01022762/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: repaglinide|DRUG: gliclazide
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Week 0, week 16 | Secondary: Change in Fasting Plasma Glucose, Week 0, week 16|Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal, A standard meal contains 100g carbohydrate, Week 0, week 16|Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%, Week 16|Change in Fasting Serum Free Fatty Acid (FFA) From Baseline, Week 0, week 16|Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal, Week 0, week 16|Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test), Over the course of three hours at Week 0 and Week 16|Change in AUC0-180 of Plasma Glucose Concentration of IVGTT, Over the course of three hours at Week 0 and Week 16|Number of All Treatment Emergent Hypoglycaemic Episodes, 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., Weeks 0-16|Cholesterol, 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., Week 0, week 16|Change in Body Weight, Week 0, week 16
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 440
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2010-11
Results First Posted: 2011-12-29
Last Update Posted: 2014-07-09
Locations: Shanghai, Shanghai, 200025, China
URL: https://clinicaltrials.gov/show/NCT01022762