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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401243
• Other study ID #: GLARGL07496
• Secondary ID: U1111-1168-5158
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2015
• Last updated: March 25, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE (U300)
Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous

Locations

Country	Name	City	State
Canada	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	Levis
Canada	Investigational Site Number 124018	London
Canada	Investigational Site Number 124003	Oshawa
Canada	Investigational Site Number 124010	Quebec
Canada	Investigational Site Number 124012	Quebec
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients reaching fasting SMPG =5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe)		12 weeks	Yes
Secondary	Percentage of patients with adverse events		12 weeks	Yes