Self Titration With Apidra to Reach Target Study (START)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01013571
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Apidra (insulin glulisine) 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed 2 Apidra (insulin glulisine) 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed 2 insulin glargine 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed 1 insulin glargine 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed
- Primary Outcome Measures
Name Time Method Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia at week 36 (end of study)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇦Laval, Canada