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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin glulisine
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014