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

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ClinicalTrials.gov Identifier: NCT02401243
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INSULIN GLARGINE (U300) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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
Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Other Name: 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
Drug: INSULIN GLARGINE (U300)

Pharmaceutical form: pre-filled disposable pen

Route of administration: subcutaneous

Other Name: HOE901




Primary Outcome Measures :
  1. 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 Measures :
  1. Percentage of patients with adverse events [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401243


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

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02401243     History of Changes
Other Study ID Numbers: GLARGL07496
U1111-1168-5158 ( Other Identifier: UTN )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs