Clinical trial NCT01013571: Self Titration With Apidra to Reach Target Study (START)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 493
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
timeFrame: at week 36 (end of study)
Secondary outcomes:
measure: Change in HbA1c, FG, and 7-point glucose profile
timeFrame: from Week 12 (randomization) to Week 24 and Week 36
measure: Change in weight
timeFrame: from Week 12 to Week 24 and to Week 36
measure: Incidence of hypoglycemia
timeFrame: Week 12 , Week 24 and Week 36
measure: Treatment satisfaction (DTSQ for patient )
timeFrame: from Week 12 to Week 36
measure: Adherence with the patient-managed monitoring algorithm
timeFrame: Week 12 , Week 24 and Week 36
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Harris SB, Yale JF, Berard L, Stewart J, Abbaszadeh B, Webster-Bogaert S, Gerstein HC. Does a patient-managed insulin intensification strategy with insulin glargine and insulin glulisine provide similar glycemic control as a physician-managed strategy? Results of the START (Self-Titration With Apidra to Reach Target) Study: a randomized noninferiority trial. Diabetes Care. 2014;37(3):604-10. doi: 10.2337/dc13-1636. Epub 2013 Oct 29.