Self Titration With Apidra to Reach Target Study (START)

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

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.