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

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ClinicalTrials.gov Identifier: NCT00964574
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: INSULIN GLULISINE (HMR1964) Drug: INSULIN GLARGINE Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

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



Outcome Measures

Primary Outcome Measures :
  1. Mean change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Mean Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 12 ]
  2. Mean Fasting Blood Glucose and mean Post Prandial Glycemia [ Time Frame: Week 12 ]
  3. Number of documented symptomatic hypoglycaemic episodes [ Time Frame: From week 0 to week 12 ]
  4. Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline [ Time Frame: week 12 ]
  5. Mean change of Fasting Blood Glucose and Post Prandial Glycemia [ Time Frame: From week 0 to week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964574


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00964574     History of Changes
Other Study ID Numbers: APIDR_L_02483
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

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
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs