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

NCT ID: NCT02401243

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (INSIGHT titration algorithm)

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

Group Type: EXPERIMENTAL

INSULIN GLARGINE (U300)

Intervention Type: DRUG

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Cohort 2 (EDITION titration algorithm)

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

Group Type: EXPERIMENTAL

INSULIN GLARGINE (U300)

Intervention Type: DRUG

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Interventions

INSULIN GLARGINE (U300)

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

HOE901

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 124001

Abbotsford, , Canada

Investigational Site Number 124013

Brampton, , Canada

Investigational Site Number 124008

Burlington, , Canada

Investigational Site Number 124024

Burnaby, , Canada

Investigational Site Number 124015

Collingwood, , Canada

Investigational Site Number 124025

Corunna, , Canada

Investigational Site Number 124019

Etobicoke, , Canada

Investigational Site Number 124021

Hamilton, , Canada

Investigational Site Number 124011

Laval, , Canada

Investigational Site Number 124005

Lévis, , Canada

Investigational Site Number 124018

London, , Canada

Investigational Site Number 124003

Oshawa, , Canada

Investigational Site Number 124010

Québec, , Canada

Investigational Site Number 124012

Québec, , Canada

Investigational Site Number 124007

Sarnia, , Canada

Investigational Site Number 124002

Saskatoon, , Canada

Investigational Site Number 124023

Sherbrooke, , Canada

Investigational Site Number 124009

Smiths Falls, , Canada

Investigational Site Number 124017

Strathroy, , Canada

Investigational Site Number 124020

Toronto, , Canada

Investigational Site Number 124006

Vancouver, , Canada

Investigational Site Number 124026

Vancouver, , Canada

Investigational Site Number 124004

Victoria, , Canada

Investigational Site Number 124014

Winnipeg, , Canada

Investigational Site Number 124016

Winnipeg, , Canada

Countries

Canada

Other Identifiers

U1111-1168-5158

Identifier Type: OTHER

Identifier Source: secondary_id

GLARGL07496

Identifier Type: -

Identifier Source: org_study_id