Self Titration With Apidra to Reach Target Study (START)

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: insulin glargine; Drug: Apidra (insulin glulisine)

• Study Type: Interventional
• Enrollment (Actual): 493
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Laval, Canada
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): March 21, 2012
• Last Update Submitted That Met QC Criteria: March 20, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
• Other Study ID Numbers: LANTU_L_04695

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No