A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

• Status: Completed
• Trial end date: 2017-12-22

Summary

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

• Targeted HbA1c;

• Targeted fasting self- monitoring blood glucose (SMBG);

• Hypoglycemic events;

• Adverse events;

• Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);

• Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: 2,4-thiazolidinedione; Glycoside Hydrolase Inhibitors; Insulin; Insulin Glargine; Insulin, Globin Zinc; Meglitinide; Metformin