Clinical trial NCT02954692: 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
Official title: A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

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.

Primary outcomes:
measure: Mean change from baseline in HbA1c
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL
timeFrame: At Weeks 12 and 24
measure: Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)
timeFrame: At Weeks 12 and 24
measure: Duration to reach target pre-breakfast SMBG
timeFrame: Baseline, Week 24
measure: Mean change from baseline in HbA1c
timeFrame: Baseline, Week 12
measure: Mean change from baseline in SMBG
timeFrame: Baseline, Weeks 12, and 24
measure: Mean change from baseline in fasting plasma glucose (FPG)
timeFrame: Baseline, Weeks 12, and 24
measure: Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Turkey
country: Turkey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: