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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: 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

• Registration Number: NCT02954692
• Lead Sponsor: Sanofi

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).

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-03
• Study Start: 2016-11-30
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin glargine (U300)	thiazolidinediones	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.
Insulin glargine (U300)	sulfonylurea	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.
Insulin glargine (U300)	Dipeptidyl peptidase-IV (DPP-IV) inhibitors	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.
Insulin glargine (U300)	alpha-glucosidase inhibitors	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.
Insulin glargine (U300)	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.
Insulin glargine (U300)	meglitinides	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.
Insulin glargine (U300)	GLP1 Receptor Agonist	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.
Insulin glargine (U300)	Sodium-glucose transport-2 (SGLT-2) inhibitors	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.
Insulin glargine (U300)	metformin	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.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in HbA1c	Baseline, Week 24

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in HbA1c	Baseline, Week 12
Mean change from baseline in fasting plasma glucose (FPG)	Baseline, Weeks 12, and 24
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 SMBG	Baseline, Weeks 12, and 24
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores	Baseline, Week 24