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

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.

Timeline

Start

2016-11-30

Primary completion

2017-12-22

Completion

2017-12-22

Drugs

Indications