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Self Titration With Apidra to Reach Target Study (START)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01013571
First received: November 12, 2009
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: insulin glargine
Drug: Apidra (insulin glulisine)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia [ Time Frame: at week 36 (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c, FG, and 7-point glucose profile [ Time Frame: from Week 12 (randomization) to Week 24 and Week 36 ] [ Designated as safety issue: No ]
  • Change in weight [ Time Frame: from Week 12 to Week 24 and to Week 36 ] [ Designated as safety issue: No ]
  • Incidence of hypoglycemia [ Time Frame: Week 12 , Week 24 and Week 36 ] [ Designated as safety issue: No ]
  • Treatment satisfaction (DTSQ for patient ) [ Time Frame: from Week 12 to Week 36 ] [ Designated as safety issue: No ]
  • Adherence with the patient-managed monitoring algorithm [ Time Frame: Week 12 , Week 24 and Week 36 ] [ Designated as safety issue: No ]

Enrollment: 493
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013571

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01013571     History of Changes
Other Study ID Numbers: LANTU_L_04695
Study First Received: November 12, 2009
Last Updated: March 20, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013