Insulin Glulisine in Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297583
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : December 7, 2009
Information provided by:

February 20, 2006
February 28, 2006
December 7, 2009
April 2004
May 2004   (Final data collection date for primary outcome measure)
serum insulin concentrations [ Time Frame: During the Study Conduct ]
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Complete list of historical versions of study NCT00297583 on Archive Site
  • glucose infusion rates [ Time Frame: During the study conduct ]
  • blood glucose concentrations [ Time Frame: During the study conduct ]
  • Adverse events and hypoglycemic episodes collection [ Time Frame: from the inform consnet signed up to the end of the study ]
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Insulin Glulisine in Type 1 Diabetes Mellitus
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.

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.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Drug: Insulin Glulisine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Medical Affairs Study Director, sanofi-aventis
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Study Director: Valérie Pilorget Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP