NCT02401243

Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

A Pilot Descriptive Canadian, Multicenter, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: The primary objective of this study is to obtain efficacy and safety descriptive data on 2 different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients. Secondary Objective: The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin \[A1C\], fasting plasma glucose \[FPG\], 7-point self-measure plasma glucose \[SMPG\], insulin dose and weight) and determine patient related outcome and health care professional satisfaction as it pertains to each titration regimen.

Detailed description

The total study duration is approximately 14 weeks (2 weeks screening and 12 weeks treatment) with a 2-day safety follow-up and a study extension of 12 weeks for eligible patients.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INSULIN GLARGINE (U300)	Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-03-27
• Last updated: 2016-03-28

Locations

25 sites across 1 country: Canada