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

March 25, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Abbotsford, Canada, V2S3N5
        • Investigational Site Number 124001
      • Brampton, Canada, L6T4V3
        • Investigational Site Number 124013
      • Burlington, Canada
        • Investigational Site Number 124008
      • Burnaby, Canada, V5G1T4
        • Investigational Site Number 124024
      • Collingwood, Canada, L9Y1W3
        • Investigational Site Number 124015
      • Corunna, Canada, N0N 1G0
        • Investigational Site Number 124025
      • Etobicoke, Canada, M9V4V4
        • Investigational Site Number 124019
      • Hamilton, Canada
        • Investigational Site Number 124021
      • Laval, Canada, H7T 2P5
        • Investigational Site Number 124011
      • Levis, Canada, G6W5M6
        • Investigational Site Number 124005
      • London, Canada, N5W 6A2
        • Investigational Site Number 124018
      • Oshawa, Canada
        • Investigational Site Number 124003
      • Quebec, Canada, G1W4R4
        • Investigational Site Number 124010
      • Quebec, Canada
        • Investigational Site Number 124012
      • Sarnia, Canada, N7T 4R9
        • Investigational Site Number 124007
      • Saskatoon, Canada, S7K 3H3
        • Investigational Site Number 124002
      • Sherbrooke, Canada, J1G5K2
        • Investigational Site Number 124023
      • Smiths Falls, Canada, K7A4W8
        • Investigational Site Number 124009
      • Strathroy, Canada, N7G1Y7
        • Investigational Site Number 124017
      • Toronto,, Canada, M8V3X8
        • Investigational Site Number 124020
      • Vancouver, Canada, V5Z1M9
        • Investigational Site Number 124006
      • Vancouver, Canada, V6J1S3
        • Investigational Site Number 124026
      • Victoria, Canada, V8V4H1
        • Investigational Site Number 124004
      • Winnipeg, Canada, R2V4W3
        • Investigational Site Number 124014
      • Winnipeg, Canada, R3E 3P4
        • Investigational Site Number 124016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Other Names:
  • HOE901
Experimental: 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

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Other Names:
  • HOE901

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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