- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401243
Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients (TITRATION)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Abbotsford, Canada, V2S3N5
- Investigational Site Number 124001
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Brampton, Canada, L6T4V3
- Investigational Site Number 124013
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Burlington, Canada
- Investigational Site Number 124008
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Burnaby, Canada, V5G1T4
- Investigational Site Number 124024
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Collingwood, Canada, L9Y1W3
- Investigational Site Number 124015
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Corunna, Canada, N0N 1G0
- Investigational Site Number 124025
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Etobicoke, Canada, M9V4V4
- Investigational Site Number 124019
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Hamilton, Canada
- Investigational Site Number 124021
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Laval, Canada, H7T 2P5
- Investigational Site Number 124011
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Levis, Canada, G6W5M6
- Investigational Site Number 124005
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London, Canada, N5W 6A2
- Investigational Site Number 124018
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Oshawa, Canada
- Investigational Site Number 124003
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Quebec, Canada, G1W4R4
- Investigational Site Number 124010
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Quebec, Canada
- Investigational Site Number 124012
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Sarnia, Canada, N7T 4R9
- Investigational Site Number 124007
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Saskatoon, Canada, S7K 3H3
- Investigational Site Number 124002
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Sherbrooke, Canada, J1G5K2
- Investigational Site Number 124023
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Smiths Falls, Canada, K7A4W8
- Investigational Site Number 124009
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Strathroy, Canada, N7G1Y7
- Investigational Site Number 124017
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Toronto,, Canada, M8V3X8
- Investigational Site Number 124020
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Vancouver, Canada, V5Z1M9
- Investigational Site Number 124006
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Vancouver, Canada, V6J1S3
- Investigational Site Number 124026
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Victoria, Canada, V8V4H1
- Investigational Site Number 124004
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Winnipeg, Canada, R2V4W3
- Investigational Site Number 124014
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Winnipeg, Canada, R3E 3P4
- Investigational Site Number 124016
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLARGL07496
- U1111-1168-5158 (Other Identifier: UTN)
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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