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)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Turkey, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in HbA1c	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL	At Weeks 12 and 24
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)	At Weeks 12 and 24
Duration to reach target pre-breakfast SMBG	Baseline, Week 24
Mean change from baseline in HbA1c	Baseline, Week 12
Mean change from baseline in SMBG	Baseline, Weeks 12, and 24
Mean change from baseline in fasting plasma glucose (FPG)	Baseline, Weeks 12, and 24
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores	Baseline, Week 24

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 30, 2016
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): December 22, 2017

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Metformin; Insulin Glargine; 2,4-thiazolidinedione; Glycoside Hydrolase Inhibitors; Meglitinide
• Other Study ID Numbers: GLARGL07921; U1111-1183-8755 (Other Identifier: UTN)