NCT02836704

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

Comparison of Efficacy and Safety of Standard vs Higher Starting Dose of Insulin Glargine in Overweight and Obese Chinese Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 892 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	INSULIN GLARGINE	Pharmaceutical form: solution Route of administration: subcutaneous injection
DRUG	metformin	Pharmaceutical form: table or capsule Route of administration: oral administration
DRUG	acarbose	Pharmaceutical form: table or capsule Route of administration: oral administration

Timeline

• Start date: 2016-09-09
• Primary completion: 2018-04-26
• Completion: 2018-04-26
• First posted: 2016-07-19
• Last updated: 2022-04-25

Locations

1 site across 1 country: China