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

Type 2 Diabetes Mellitus Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954692
• Other study ID #: GLARGL07921
• Secondary ID: U1111-1183-8755
• Status: Completed
• Phase: Phase 4
• Start date: November 30, 2016
• Est. completion date: December 22, 2017

Study information

• Verified date: January 2019
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE (U300)
Pharmaceutical form: pen for injection Route of administration: subcutaneous
• metformin
Pharmaceutical form: tablet Route of administration: oral
• sulfonylurea
Pharmaceutical form: tablet Route of administration: oral
• meglitinides
Pharmaceutical form: tablet Route of administration: oral
• thiazolidinediones
Pharmaceutical form: tablet Route of administration: oral
• alpha-glucosidase inhibitors
Pharmaceutical form: tablet Route of administration: oral
• GLP1 Receptor Agonist
Pharmaceutical form: pen for injection Route of administration: subcutaneous
• Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Pharmaceutical form: tablet Route of administration: oral
• Sodium-glucose transport-2 (SGLT-2) inhibitors
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in HbA1c		Baseline, Week 24
Secondary	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
Secondary	Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)		At Weeks 12 and 24
Secondary	Duration to reach target pre-breakfast SMBG		Baseline, Week 24
Secondary	Mean change from baseline in HbA1c		Baseline, Week 12
Secondary	Mean change from baseline in SMBG		Baseline, Weeks 12, and 24
Secondary	Mean change from baseline in fasting plasma glucose (FPG)		Baseline, Weeks 12, and 24
Secondary	Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores		Baseline, Week 24