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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

NCT02954692

CompletedPhase 4

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: INSULIN GLARGINE (U300), metformin, sulfonylurea, meglitinides, thiazolidinediones

Countries: Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Turkey, Turkey (Türkiye)