Clinical trial NCT02401243: Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Patients with type 2 diabetes mellitus.
* Patients who are ≥18 years of age.
* Treated for diabetes for at least 6 months.

  * If on basal insulin, stable for at least 3 months prior to screening visit on their basal insulin treatment(s) (±20% total insulin dose)
  * If on NIAHA, stable for at least 8 weeks prior to screening visit on their NIAHA(s) (no change in dose or initiation of new NIAHAs).
* Patients on uncontrolled basal insulin (insulin glargine, normal protamine Hagedorn \[NPH\], detemir) +/ NIAHAs with an A1c \>7.0% and ≤10% or uncontrolled on NIAHAs (insulin naïve patients) with an A1c \>7.0% and ≤11%.
* Signed informed consent form.

Exclusion criteria:

* Patients with type 1 diabetes mellitus (T1DM).
* Nightshift worker.
* Female patients who are pregnant or lactating.
* Treatment with an insulin other than basal insulin (premixes, rapid insulin, fast acting insulin analogues) within the previous 3 months.
* Patients with less than 1 year history of diabetes.
* Patients unwilling to inject insulin or perform self-monitoring blood glucose.
* Current alcohol or drug abuse.
* Patients unlikely to comply with the protocol and complete the study eg, uncooperative attitude, inability to return for follow-up visits.
* Patients with active cancer or any other diseases or conditions which in the opinion of the Investigator would make the patient unsuitable for participation in the study.
* Any clinically significant laboratory findings that in the judgment of the Investigator would preclude safe completion of the study.
* Known allergies to study drugs.
* Participation in another clinical study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of patients with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Investigational Site Number 124001
city: Brampton
country: Canada
facility: Investigational Site Number 124013
city: Burlington
country: Canada
facility: Investigational Site Number 124008
city: Burnaby
country: Canada
facility: Investigational Site Number 124024
city: Collingwood
country: Canada
facility: Investigational Site Number 124015
city: Corunna
country: Canada
facility: Investigational Site Number 124025
city: Etobicoke
country: Canada
facility: Investigational Site Number 124019
city: Hamilton
country: Canada
facility: Investigational Site Number 124021
city: Laval
country: Canada
facility: Investigational Site Number 124011
city: Levis
country: Canada
facility: Investigational Site Number 124005
city: London
country: Canada
facility: Investigational Site Number 124018
city: Oshawa
country: Canada
facility: Investigational Site Number 124003
city: Quebec
country: Canada
facility: Investigational Site Number 124010
city: Quebec
country: Canada
facility: Investigational Site Number 124012
city: Sarnia
country: Canada
facility: Investigational Site Number 124007
city: Saskatoon
country: Canada
facility: Investigational Site Number 124002
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124023
city: Smiths Falls
country: Canada
facility: Investigational Site Number 124009
city: Strathroy
country: Canada
facility: Investigational Site Number 124017
city: Toronto,
country: Canada
facility: Investigational Site Number 124020
city: Vancouver
country: Canada
facility: Investigational Site Number 124006
city: Vancouver
country: Canada
facility: Investigational Site Number 124026
city: Victoria
country: Canada
facility: Investigational Site Number 124004
city: Winnipeg
country: Canada
facility: Investigational Site Number 124014
city: Winnipeg
country: Canada
facility: Investigational Site Number 124016
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: