Overview

Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)

Status:
Completed

Trial end date:
2018-04-26

Target enrollment:

Participant gender:

Summary

Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs). Secondary Objective: - To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) <7%. - To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (<5.6, <6.1, and <7.0 mmol/L). - To assess the changes in HbA1c, FPG, and postprandial glucose (PPG). - To evaluate the insulin doses change. - To evaluate the weight change. - To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence. - To descriptively evaluate the safety profile. - To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration). - Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to: - Age - Duration of diabetes - Baseline treatment (OAD) - Baseline HbA1c, FPG and PP

Phase:

Phase 4

Details

Lead Sponsor:

Sanofi

Treatments:

Acarbose
Insulin
Insulin Glargine
Insulin, Globin Zinc
Metformin
Repaglinide
Sitagliptin Phosphate