Self Titration With Apidra to Reach Target Study (START)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin glargine
* Drug: Apidra (insulin glulisine)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Run-in phase: T2DM Treated for at least 3 months with a basal insulin (insulin glargine, NPH, detemir) +/- oral antidiabetic drugs (OADs) with an HbA1c >7.0% or insulin naive (2-3 OADs) with an HbA1c >=7.8% (historic HbA1c result up to 3 months of screening is acceptable) Randomized treatment phase: Completed run-in phase HbA1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (BG <4.0 mmol/L) or >= 2 measurements of FG <=6.0 mmol/L within the previous week Patients who completed the run-in phase with HbA1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study. 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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed | Drug: insulin glargine<br>* pre-filled disposable pen, in package of 5.<br>Drug: Apidra (insulin glulisine)<br>* pre-filled disposable pen, in package of 5<br>|
| Experimental: 2<br>12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed | Drug: insulin glargine<br>* pre-filled disposable pen, in package of 5.<br>Drug: Apidra (insulin glulisine)<br>* pre-filled disposable pen, in package of 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia |  | at week 36 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |