Skip to main content
OpenTrials
Completed

NCT Number: NCT01013571

Self Titration With Apidra to Reach Target Study (START)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Laval, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

pre-filled disposable pen, in package of 5.

Apidra (insulin glulisine)

Drug

pre-filled disposable pen, in package of 5

Primary outcomes

  1. Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia

    Time frame: at week 36 (end of study)

Secondary outcomes

  1. Change in HbA1c, FG, and 7-point glucose profile

    Time frame: from Week 12 (randomization) to Week 24 and Week 36

  2. Change in weight

    Time frame: from Week 12 to Week 24 and to Week 36

  3. Incidence of hypoglycemia

    Time frame: Week 12 , Week 24 and Week 36

  4. Treatment satisfaction (DTSQ for patient )

    Time frame: from Week 12 to Week 36

  5. Adherence with the patient-managed monitoring algorithm

    Time frame: Week 12 , Week 24 and Week 36

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 13, 2009
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.