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Self Titration With Apidra to Reach Target Study (START)

NCT01013571 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2012-03-21

No results posted yet for this study

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin glargine

pre-filled disposable pen, in package of 5.

DRUG

Apidra (insulin glulisine)

pre-filled disposable pen, in package of 5

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01013571 on ClinicalTrials.gov