Insulin Glulisine in Type 1 Diabetes Mellitus

NCT00297583 | Completed Phase 1

• 1 other identifier: HMR1964A_1501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• serum insulin concentrations

  During the Study Conduct

Secondary Outcomes (3)

• glucose infusion rates

  During the study conduct

• blood glucose concentrations

  During the study conduct

• Adverse events and hypoglycemic episodes collection

  from the inform consnet signed up to the end of the study

Interventions

Insulin Glulisine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications from:
• The medical history and physical examination
• Laboratory tests (hematology, clinical chemistry and urinalysis)
• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Valérie Pilorget

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 28, 2006
• Study Start: April 1, 2004
• Primary Completion: May 1, 2004
• Last Updated: December 7, 2009

Record last verified: 2009-12