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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: INSULIN GLARGINE (U300)

• Registration Number: NCT02401243
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 (EDITION titration algorithm)	INSULIN GLARGINE (U300)	INSULIN GLARGINE (U300): titration of insulin glargine 300 units/mL (U300) will be adjusted weekly or not more than every 3 days to achieve the target range of fasting SMPG of 4.4 to 5.6 mmol/L
Cohort 1 (INSIGHT titration algorithm)	INSULIN GLARGINE (U300)	INSULIN GLARGINE (U300): self-titration of insulin glargine 300 units/mL (U300) will be increased daily by 1 unit until fasting SMPG reaches the target range of 4.4 to 5.6 mmol/L

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with adverse events	12 weeks

Trial Locations

Locations (25)

Investigational Site Number 124004; 🇨🇦 Victoria, Canada

Investigational Site Number 124026; 🇨🇦 Vancouver, Canada

Investigational Site Number 124006; 🇨🇦 Vancouver, Canada

Investigational Site Number 124024; 🇨🇦 Burnaby, Canada

Investigational Site Number 124015; 🇨🇦 Collingwood, Canada

Investigational Site Number 124005; 🇨🇦 Levis, Canada

Investigational Site Number 124017; 🇨🇦 Strathroy, Canada

Investigational Site Number 124020; 🇨🇦 Toronto,, Canada

Investigational Site Number 124016; 🇨🇦 Winnipeg, Canada

Investigational Site Number 124021; 🇨🇦 Hamilton, Canada

Investigational Site Number 124001; 🇨🇦 Abbotsford, Canada

Investigational Site Number 124013; 🇨🇦 Brampton, Canada

Investigational Site Number 124025; 🇨🇦 Corunna, Canada

Investigational Site Number 124019; 🇨🇦 Etobicoke, Canada

Investigational Site Number 124011; 🇨🇦 Laval, Canada

Investigational Site Number 124018; 🇨🇦 London, Canada

Investigational Site Number 124003; 🇨🇦 Oshawa, Canada

Investigational Site Number 124012; 🇨🇦 Quebec, Canada

Investigational Site Number 124007; 🇨🇦 Sarnia, Canada

Investigational Site Number 124010; 🇨🇦 Quebec, Canada

Investigational Site Number 124023; 🇨🇦 Sherbrooke, Canada

Investigational Site Number 124002; 🇨🇦 Saskatoon, Canada

Investigational Site Number 124009; 🇨🇦 Smiths Falls, Canada

Investigational Site Number 124014; 🇨🇦 Winnipeg, Canada

Investigational Site Number 124008; 🇨🇦 Burlington, Canada