EASE: 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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT02954692

Collaborator

(none)

112

Enrollment

Location

Arm

12.7

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: INSULIN GLARGINE (U300) Drug: metformin Drug: sulfonylurea Drug: meglitinides Drug: thiazolidinediones Drug: alpha-glucosidase inhibitors Drug: GLP1 Receptor Agonist Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 30, 2016

Actual Primary Completion Date :

Dec 22, 2017

Actual Study Completion Date :

Dec 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin glargine (U300) 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.	Drug: INSULIN GLARGINE (U300) Pharmaceutical form: pen for injection Route of administration: subcutaneous Other Names: HOE901 Drug: metformin Pharmaceutical form: tablet Route of administration: oral Drug: sulfonylurea Pharmaceutical form: tablet Route of administration: oral Drug: meglitinides Pharmaceutical form: tablet Route of administration: oral Drug: thiazolidinediones Pharmaceutical form: tablet Route of administration: oral Drug: alpha-glucosidase inhibitors Pharmaceutical form: tablet Route of administration: oral Drug: GLP1 Receptor Agonist Pharmaceutical form: pen for injection Route of administration: subcutaneous Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors Pharmaceutical form: tablet Route of administration: oral Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors Pharmaceutical form: tablet Route of administration: oral

Arm

Intervention/Treatment

Experimental: Insulin glargine (U300)

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.

Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: pen for injection Route of administration: subcutaneous

Other Names:

HOE901

Drug: metformin