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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
INSULIN GLARGINE (U300)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 124001
  • Investigational Site Number 124013
  • Investigational Site Number 124008
  • Investigational Site Number 124024
  • Investigational Site Number 124015
  • Investigational Site Number 124025
  • Investigational Site Number 124019
  • Investigational Site Number 124021
  • Investigational Site Number 124011
  • Investigational Site Number 124005
  • Investigational Site Number 124018
  • Investigational Site Number 124003
  • Investigational Site Number 124010
  • Investigational Site Number 124012
  • Investigational Site Number 124007
  • Investigational Site Number 124002
  • Investigational Site Number 124023
  • Investigational Site Number 124009
  • Investigational Site Number 124017
  • Investigational Site Number 124020
  • Investigational Site Number 124006
  • Investigational Site Number 124026
  • Investigational Site Number 124004
  • Investigational Site Number 124014
  • Investigational Site Number 124016

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 (INSIGHT titration algorithm)

Cohort 2 (EDITION titration algorithm)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with adverse events

Full Information

First Posted
March 24, 2015
Last Updated
March 25, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02401243
Brief Title
Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients
Acronym
TITRATION
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (INSIGHT titration algorithm)
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2 (EDITION titration algorithm)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE (U300)
Other Intervention Name(s)
HOE901
Intervention Description
Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of patients with adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 124001
City
Abbotsford
ZIP/Postal Code
V2S3N5
Country
Canada
Facility Name
Investigational Site Number 124013
City
Brampton
ZIP/Postal Code
L6T4V3
Country
Canada
Facility Name
Investigational Site Number 124008
City
Burlington
Country
Canada
Facility Name
Investigational Site Number 124024
City
Burnaby
ZIP/Postal Code
V5G1T4
Country
Canada
Facility Name
Investigational Site Number 124015
City
Collingwood
ZIP/Postal Code
L9Y1W3
Country
Canada
Facility Name
Investigational Site Number 124025
City
Corunna
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
Investigational Site Number 124019
City
Etobicoke
ZIP/Postal Code
M9V4V4
Country
Canada
Facility Name
Investigational Site Number 124021
City
Hamilton
Country
Canada
Facility Name
Investigational Site Number 124011
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 124005
City
Levis
ZIP/Postal Code
G6W5M6
Country
Canada
Facility Name
Investigational Site Number 124018
City
London
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Investigational Site Number 124003
City
Oshawa
Country
Canada
Facility Name
Investigational Site Number 124010
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
Investigational Site Number 124012
City
Quebec
Country
Canada
Facility Name
Investigational Site Number 124007
City
Sarnia
ZIP/Postal Code
N7T 4R9
Country
Canada
Facility Name
Investigational Site Number 124002
City
Saskatoon
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Investigational Site Number 124023
City
Sherbrooke
ZIP/Postal Code
J1G5K2
Country
Canada
Facility Name
Investigational Site Number 124009
City
Smiths Falls
ZIP/Postal Code
K7A4W8
Country
Canada
Facility Name
Investigational Site Number 124017
City
Strathroy
ZIP/Postal Code
N7G1Y7
Country
Canada
Facility Name
Investigational Site Number 124020
City
Toronto,
ZIP/Postal Code
M8V3X8
Country
Canada
Facility Name
Investigational Site Number 124006
City
Vancouver
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Investigational Site Number 124026
City
Vancouver
ZIP/Postal Code
V6J1S3
Country
Canada
Facility Name
Investigational Site Number 124004
City
Victoria
ZIP/Postal Code
V8V4H1
Country
Canada
Facility Name
Investigational Site Number 124014
City
Winnipeg
ZIP/Postal Code
R2V4W3
Country
Canada
Facility Name
Investigational Site Number 124016
City
Winnipeg
ZIP/Postal Code
R3E 3P4
Country
Canada

12. IPD Sharing Statement

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

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