Type 2 Diabetes MellitusPhase 1NCT00310297
Insulin Glulisine in Type 2 Diabetes Mellitus
A Phase 1 study testing Insulin Glulisine in people with Type 2 Diabetes Mellitus, run by Sanofi.
Trial summary
Primary objective: To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Glulisine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 2004to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Body mass index (BMI) between 35 and 40 kg/m2
- HbA1c ≤10%
- Plasma C-peptide levels ≥0.1 nmol/L.
- Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.
Who cannot join
- Type 1 diabetes mellitus, as defined by the World Health Organization
- Subjects currently taking any insulin
- History of hypoglycaemic unawareness
- Injection site skin thickness < or = 8 mm
- Contra-indications from
- The medical history and physical examination
- Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
- Blood pressure and pulse
About this study
Official title: A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.
Primary objective:
To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.
Secondary objectives:
- To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
- The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Glulisine
- Medical subject headings
- Diabetes Mellitus, Type 2
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.
Maximum plasma glucose concentration (GLUmax, mmol/L)
Measured: During the Study Conduct
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
Measured: during the study conduct
Time to GLUmax (Tmax, min)
Measured: during the study conduct
Secondary outcomes (4)
Area under the insulin concentration-time curve after injection(μIU.min/mL)
Measured: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)
Maximum concentration (Cmax, μIU/mL)
Measured: During the study conduct
Adverse events collection
Measured: from the inform consnet signed up to the end of the study
Time to maximum concentration (Tmax, min)
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startNov 2004
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310297
- Sponsor's protocol ID
- HMR1964A_1505
- Status last verified
- Jul 2008
- First submitted
- 2 Mar 2006
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00310297
- Acronym / sponsor ID
- HMR1964A_1505
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 3 Apr 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.
Primary objective:
To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.
Secondary objectives:
- To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
- The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus
- Body mass index (BMI) between 35 and 40 kg/m2
- HbA1c ≤10%
- Plasma C-peptide levels ≥0.1 nmol/L.
- Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus, as defined by the World Health Organization
- Subjects currently taking any insulin
- History of hypoglycaemic unawareness
- Injection site skin thickness < or = 8 mm
- Contra-indications from
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
Maximum plasma glucose concentration (GLUmax, mmol/L)
Time frame: During the Study Conduct
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
Time frame: during the study conduct
Time to GLUmax (Tmax, min)
Time frame: during the study conduct
4 secondary outcomes
Area under the insulin concentration-time curve after injection(μIU.min/mL)
Time frame: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)
Maximum concentration (Cmax, μIU/mL)
Time frame: During the study conduct
Adverse events collection
Time frame: from the inform consnet signed up to the end of the study
Time to maximum concentration (Tmax, min)
Time frame: During the study conduct
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 11 Jan 2011.
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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, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin Glulisine in people with Type 2 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 5 inclusion and 8 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 11 Jan 2011. 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?
Maximum plasma glucose concentration (GLUmax, mmol/L) (time frame: During the Study Conduct). The study lists 3 primary outcomes in all. 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 11 Jan 2011.