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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria :

• Adult patients with type 2 diabetes mellitus (≥18 years of age).

• Type 2 diabetes mellitus diagnosis ≥1 year.

• Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).

• Stable antidiabetic treatment for at least 3 months.

• Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).

• Signed informed consent obtained.

Exclusion criteria:

• Age <18 years old.

• Type 1 diabetes mellitus.

• Having secondary type 2 diabetes mellitus.

• Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.

• History of hypoglycemia unawareness.

• Known hypersensitivity/intolerance to insulin glargine or any of its excipients.

• Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.

• Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.

• Pregnant or lactating women.

• Participation in another clinical trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.