Self Titration With Apidra to Reach Target Study (START)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Apidra (insulin glulisine); Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013571

LANTU_L_04695

Details and patient eligibility

About

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

Enrollment: 493 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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493 participants in 2 patient groups

1

Experimental group

Description:

12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed

Treatment:

Drug: Apidra (insulin glulisine)

Drug: insulin glargine

2

Experimental group

Description:

12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed

Treatment:

Drug: Apidra (insulin glulisine)

Drug: insulin glargine