Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
Not provided
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