Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus (PORTAL 1)

July 16, 2012 updated by: Sanofi

Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
  • 6.5 <=HbA1c <= 11% at visit 1
  • BMI <35 kg/m²
  • Provision of signed and dated informed consent prior to any study procedures
  • Ability and willingness to complete study diaries and questionnaires
  • Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
  • A negative pregnancy test for all females of childbearing potential.

Exclusion criteria:

  • Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
  • Pregnant women
  • Active proliferative diabetic retinopathy
  • Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: APIDRA + LANTUS basal
The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12
Drug: INSULIN GLULISINE (HMR1964)

Pharmaceutical form:

APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet

Route of administration:

3-4 subcutaneous injections per day

Drug: INSULIN GLARGINE

Pharmaceutical form:

LANTUS 100U/ml solution for injection in cartridge

Route of administration:

Once daily subcutaneous injection in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Glycosylated haemoglobin (HbA1c)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Glycosylated haemoglobin (HbA1c)
Time Frame: Week 12
Week 12
Mean Fasting Blood Glucose and mean Post Prandial Glycemia
Time Frame: Week 12
Week 12
Number of documented symptomatic hypoglycaemic episodes
Time Frame: From week 0 to week 12
From week 0 to week 12
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
Time Frame: week 12
week 12
Mean change of Fasting Blood Glucose and Post Prandial Glycemia
Time Frame: From week 0 to week 12
From week 0 to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Natallia Zhyhaila, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIDR_L_02483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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