A Canadian, Phase IV, Multicenter, Comparative, Open-label Study Evaluating 2 Approaches of Blood Glucose Monitoring and Insulin Titration (Patient-managed vs Health Care Professional) in T2DM Patients While Receiving the Addition of 1 Injection of Insulin Glulisine at Breakfast Following Optimization of Insulin Glargine
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 493
- Locations
- 1
- Primary Endpoint
- Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
Study Overview
Brief Summary
Primary Objective:
The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c <=7.0% without severe hypoglycemia at the end of the study.
Secondary Objective:
Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following:
- change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36
- satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36
- change in weight at Week 24 and Week 36
- incidence of hypoglycemia
- insulin doses
- resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations)
- adherence with the patient-managed monitoring algorithm
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •No food intake before lunch (noon)
- •Unstable diet intake or significant changes to current diet regimen
- •Nightshift worker
- •Type 1 Diabetes Mellitus
- •Subjects unwilling to inject insulin or perform self-monitoring blood glucose
- •Pregnant, alcohol or drug abuse
- •Active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
- •Any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
- •Known allergies to study drugs
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Arms & Interventions
1
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed
Intervention: insulin glargine (Drug)
1
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed
Intervention: Apidra (insulin glulisine) (Drug)
2
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed
Intervention: insulin glargine (Drug)
2
12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed
Intervention: Apidra (insulin glulisine) (Drug)
Outcomes
Primary Outcomes
Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
Time Frame: at week 36 (end of study)
Secondary Outcomes
- Change in HbA1c, FG, and 7-point glucose profile(from Week 12 (randomization) to Week 24 and Week 36)
- Change in weight(from Week 12 to Week 24 and to Week 36)
- Incidence of hypoglycemia(Week 12 , Week 24 and Week 36)
- Treatment satisfaction (DTSQ for patient )(from Week 12 to Week 36)
- Adherence with the patient-managed monitoring algorithm(Week 12 , Week 24 and Week 36)