Insulin Glulisine in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00297583
First received: February 20, 2006
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects.

The secondary objectives of the study were to assess:

  • the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma nonesterified free fatty acids (NEFA) and glycerol levels
  • the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma lactate levels
  • the safety and tolerability of insulin glulisine in comparison to insulin lispro and unmodified human insulin.

Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Insulin Glulisine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blind, 3-period Cross-over Trial to Compare the Effect of Insulin Glulisine, Insulin Lispro and Unmodified Human Insulin on the Endogenous Glucose Production in Type 1 Diabetic Patients.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • serum insulin concentrations [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose infusion rates [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • blood glucose concentrations [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Adverse events and hypoglycemic episodes collection [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]

Study Start Date: April 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Type 1 diabetes (as defined by the World Health Organization) for at least 2 years
  • HbA1c ≤ 10.0 %
  • C-peptide < 0.05 nmol/L, based on fasting C-peptide level
  • Body mass index (BMI) ≤ 30 kg/m²
  • Treatment with intensified insulin therapy: short acting insulin before meals (breakfast, lunch,dinner) with neutral protamine Hagedorn (NPH) insulin, or continuous subcutaneous insulin infusion (CSII) for at least 3 months.Insulin glargine, or other basal insulin than NPH, had to be replaced by NPH insulin at the screening visit.
  • Women not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or not pregnant and agreed to use a reliable contraceptive measure for the duration of the study.
  • Able and willing to perform self-monitoring of blood glucose

Exclusion criteria

  • Contraindications from:

    • The medical history and physical examination
    • Laboratory tests (hematology, clinical chemistry and urinalysis)
    • 12-lead electrocardiogram (ECG)
    • Blood pressure and pulse rate
    • Hepatitis screen
  • Pregnancy, breast-feeding or intention to become pregnant
  • History of drug or alcohol abuse
  • Receipt of any investigational drug within the last 30 days prior to this trial
  • Experienced recurrent severe hypoglycemia or hypoglycemic unawareness (as judged by the investigator)
  • Total daily insulin dose ≥ 1.4 IU/kg
  • Serum insulin antibody level > 20 U/mL determined at screening visit
  • Smokers > 10 cigarettes per day or equivalent
  • Pre-planned surgery during the study
  • Currently being treated with systemic corticosteroids or any other drugs affecting blood glucose, or immunosuppressives
  • Known diabetic gastroparesis or lipodystrophia
  • Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study
  • Cardiac problems:

    • New York Heart Association (NYHA) Functional Capacity Class III and IV
    • Diagnosis of unstable angina pectoris
    • Myocardial infarction within the last 12 months
  • Biochemical signs of hepatic or renal diseases as indicated by alanine aminotransferase and/or alkaline phosphatase ≥ 2 times and/or creatinine ≥ 1.5 times the upper limit of the normal reference range for the age group or current renal dialysis
  • Anemia as indicated by hemoglobin < 6.2 mmol/L or clinically relevant iron deficiency as indicated by low ferritin levels in men (< 34 ng/mL) and women (premenopausal < 22 ng/mL, menopausal < 13 ng/mL)
  • Any other clinically significant major organ system disease such as relevant cardiovascular (e.g. uncontrolled hypertension), gastrointestinal, hepatic, neurologic, endocrine (e.g.pancreatic), hematologic, malignant or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult
  • Significant endogenous insulin secretion indicated by fasting C-peptide
  • History of hypersensitivity to insulin or insulin analogues or any of the excipients in the HMR
  • Donation of blood (>500 mL) during the previous 3 months prior to the screening visit or during the duration of the study
  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: NCT00297583

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00297583     History of Changes
Other Study ID Numbers: HMR1964A_1501
Study First Received: February 20, 2006
Last Updated: December 4, 2009
Health Authority: Austria: Federal Ministry for Health and Women

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

ClinicalTrials.gov processed this record on July 24, 2014