Diabetes Mellitus, Type IPhase 1NCT00368394
Dose-Exposure-Response in Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin glulisine in people with Diabetes Mellitus, Type I, run by Sanofi at 1 site in Germany.
Trial summary
To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type I
- What is being tested?
- Insulin glulisine
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to not given
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)
To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).
- Conditions
- Diabetes Mellitus, Type I
- Being tested
- Insulin glulisine
- Keywords
- Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1
- 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.
Outcome measures: Glucose infusion rate, insulin concentrations.
Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IStudies 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
- Single blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klaus Rave Dr, med, Principal investigator, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368394
- Sponsor's protocol ID
- HMR1964/1019
- Other IDs
- HMR1964
- Status last verified
- Aug 2006
- First submitted
- 23 Aug 2006
- Last updated
- 24 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)
- ClinicalTrials.gov ID
- NCT00368394
- Acronym / sponsor ID
- HMR1964/1019
- Conditions
- Diabetes Mellitus, Type I
- Keywords
- Insulin glulisine, Euglycaemic clamp, Diabetes mellitus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- First posted
- 24 Aug 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.
To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Type 1 diabetes mellitus
Key exclusion criteria (1 listed)
- -
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
Outcome measures: Glucose infusion rate, insulin concentrations.
Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.
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 24 Aug 2006.
- Related InfoLink provided by the sponsor.
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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.
Klaus Rave Dr, med principal investigator
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin glulisine in people with Diabetes Mellitus, Type I, run by Sanofi at 1 site in Germany.
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 1 inclusion and 1 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 24 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Outcome measures: Glucose infusion rate, insulin concentrations.. The study lists 2 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 24 Aug 2006.