NCT02954692

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	INSULIN GLARGINE (U300)	Pharmaceutical form: pen for injection Route of administration: subcutaneous
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

Timeline

• Start date: 2016-11-30
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2016-11-03
• Last updated: 2019-01-14

Locations

1 site across 1 country: Turkey (Türkiye)