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OpenTrials
Completed

NCT Number: NCT00964574

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Minsk, Belarus

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Insulin glulisine (HMR1964)

Drug

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

insulin glargine

Drug

Pharmaceutical form:

LANTUS 100U/ml solution for injection in cartridge

Route of administration:

Once daily subcutaneous injection in the evening

Primary outcomes

  1. Mean change in Glycosylated haemoglobin (HbA1c)

    Time frame: Week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: PORTAL 1

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Jul 17, 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.

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