Self Titration With Apidra to Reach Target Study (START)

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013571
• Other study ID #: LANTU_L_04695
• Status: Completed
• Phase: Phase 4
• First received: November 12, 2009
• Last updated: March 20, 2012
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin glargine
pre-filled disposable pen, in package of 5.
• Apidra (insulin glulisine)
pre-filled disposable pen, in package of 5

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia		at week 36 (end of study)	No
Secondary	Change in HbA1c, FG, and 7-point glucose profile		from Week 12 (randomization) to Week 24 and Week 36	No
Secondary	Change in weight		from Week 12 to Week 24 and to Week 36	No
Secondary	Incidence of hypoglycemia		Week 12 , Week 24 and Week 36	No
Secondary	Treatment satisfaction (DTSQ for patient )		from Week 12 to Week 36	No
Secondary	Adherence with the patient-managed monitoring algorithm		Week 12 , Week 24 and Week 36	No