Self Titration With Apidra to Reach Target Study (START)

NCT ID: NCT01013571

Last Updated: 2012-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 493 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-01-31

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

pre-filled disposable pen, in package of 5.

Apidra (insulin glulisine)

Intervention Type: DRUG

pre-filled disposable pen, in package of 5

2

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

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

pre-filled disposable pen, in package of 5.

Apidra (insulin glulisine)

Intervention Type: DRUG

pre-filled disposable pen, in package of 5

Interventions

insulin glargine

pre-filled disposable pen, in package of 5.

Intervention Type: DRUG

Apidra (insulin glulisine)

pre-filled disposable pen, in package of 5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Laval, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 24170757 (View on PubMed)

Other Identifiers

LANTU_L_04695

Identifier Type: -

Identifier Source: org_study_id