Type 1 Diabetes MellitusPhase 1NCT00297583
Insulin Glulisine in Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin Glulisine in people with Type 1 Diabetes Mellitus, run by Sanofi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin Glulisine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2004to May 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
About this study
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.
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
- Being tested
- Insulin Glulisine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlulisineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
serum insulin concentrations
Measured: During the Study Conduct
Secondary outcomes (3)
glucose infusion rates
Measured: During the study conduct
blood glucose concentrations
Measured: During the study conduct
Adverse events and hypoglycemic episodes collection
Measured: from the inform consnet signed up to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startApr 2004
- Primary completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297583
- Sponsor's protocol ID
- HMR1964A_1501
- Status last verified
- Dec 2009
- First submitted
- 20 Feb 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00297583
- Acronym / sponsor ID
- HMR1964A_1501
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- May 2004 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (27 listed)
- Contraindications from:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glulisine | Drug | – |
Primary outcome
serum insulin concentrations
Time frame: During the Study Conduct
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Pilorget study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin Glulisine in people with Type 1 Diabetes Mellitus, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum insulin concentrations (time frame: During the Study Conduct). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009.