- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00297583
Insulin Glulisine in Type 1 Diabetes Mellitus
December 4, 2009 updated by: Sanofi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum insulin concentrations
Time Frame: During the Study Conduct
|
During the Study Conduct
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glucose infusion rates
Time Frame: During the study conduct
|
During the study conduct
|
blood glucose concentrations
Time Frame: During the study conduct
|
During the study conduct
|
Adverse events and hypoglycemic episodes collection
Time Frame: from the inform consnet signed up to the end of the study
|
from the inform consnet signed up to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Valérie Pilorget, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
February 20, 2006
First Submitted That Met QC Criteria
February 27, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
December 7, 2009
Last Update Submitted That Met QC Criteria
December 4, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMR1964A_1501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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