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

NCT ID: NCT02954692

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-22

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).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

INSULIN GLARGINE (U300)

Intervention Type: DRUG

Pharmaceutical form: pen for injection

Route of administration: subcutaneous

metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

sulfonylurea

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

meglitinides

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

thiazolidinediones

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

alpha-glucosidase inhibitors

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

GLP1 Receptor Agonist

Intervention Type: DRUG

Pharmaceutical form: pen for injection

Route of administration: subcutaneous

Dipeptidyl peptidase-IV (DPP-IV) inhibitors

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

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

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

INSULIN GLARGINE (U300)

Pharmaceutical form: pen for injection

Route of administration: subcutaneous

Intervention Type: DRUG

metformin

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

meglitinides

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

thiazolidinediones

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

alpha-glucosidase inhibitors

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

GLP1 Receptor Agonist

Pharmaceutical form: pen for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Dipeptidyl peptidase-IV (DPP-IV) inhibitors

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

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

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

HOE901

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Turkey, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

U1111-1183-8755

Identifier Type: OTHER

Identifier Source: secondary_id

GLARGL07921

Identifier Type: -

Identifier Source: org_study_id