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 (EASE)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors

Drug: thiazolidinediones

Drug: sulfonylurea

Drug: alpha-glucosidase inhibitors

Drug: GLP1 Receptor Agonist

Drug: meglitinides

Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors

Drug: INSULIN GLARGINE (U300)

Drug: metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02954692

U1111-1183-8755 (Other Identifier)

GLARGL07921

Details and patient eligibility

About

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.

Full 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).

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

112 participants in 1 patient group

Insulin glargine (U300)

Experimental group

Description:

Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.

Treatment: