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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00964574
First received: August 24, 2009
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: INSULIN GLULISINE (HMR1964)
Drug: INSULIN GLARGINE
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Mean change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Mean Fasting Blood Glucose and mean Post Prandial Glycemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of documented symptomatic hypoglycaemic episodes [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]
  • Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Mean change of Fasting Blood Glucose and Post Prandial Glycemia [ Time Frame: From week 0 to week 12 ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00964574

Locations
Belarus
Sanofi-Aventis Administrative Office
Minsk, Belarus
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Natallia Zhyhaila Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00964574     History of Changes
Other Study ID Numbers: APIDR_L_02483
Study First Received: August 24, 2009
Last Updated: July 16, 2012
Health Authority: Belarus: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014