Type 1 Diabetes MellitusPhase 1NCT01349855
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin glargine HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen Secondary Objective: To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glargine HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to May 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
- Body weight between 50.0 kg and 110.0 kg,
- Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
- Stable insulin regimen for at least 2 months prior to study
- Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination
- Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm; cervical/vault cap; 3) spermicide.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
- Participation in a trial with any investigational drug during the past three months
- Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
- Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days
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- Known hypersensitivity to insulin glargine or excipients of the study drug
- Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1
Primary Objective:
To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen
Secondary Objective:
To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
Read the detailed description
The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glargine HOE901
- 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 glargine HOE901Drug
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose Level 1 Receives: Drug: Insulin glargine HOE901 |
| Cohort 2 | Experimental | Dose Level 2 Receives: Drug: Insulin glargine HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
Measured: up to day 10 of each period
Secondary outcomes (4)
Glucose infusion rate
Measured: up to day 10 of each period
Pharmacokinetic parameter : Cmax
Measured: up to day 10 of each period
Pharmacokinetic parameter : Tmax
Measured: up to day 10 of each period
Pharmacokinetic parameter : AUC
Measured: up to day 10 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349855
- Sponsor's protocol ID
- TDR11626
- Other IDs
- 2010-023771-26
- Status last verified
- May 2011
- First submitted
- 15 Apr 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.
PubMed 25150159
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1
- ClinicalTrials.gov ID
- NCT01349855
- Acronym / sponsor ID
- TDR11626
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 May 2011 (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 assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen
Secondary Objective:
To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
Detailed description
The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Insulin glargine HOE901Dose Level 1 |
| Cohort 2 | Experimental | Drug: Insulin glargine HOE901Dose Level 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
- Body weight between 50.0 kg and 110.0 kg,
- Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
- Stable insulin regimen for at least 2 months prior to study
- Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination
Key exclusion criteria (9 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
- Participation in a trial with any investigational drug during the past three months
- Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
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 glargine HOE901Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
Time frame: up to day 10 of each period
4 secondary outcomes
Glucose infusion rate
Time frame: up to day 10 of each period
Pharmacokinetic parameter : Cmax
Time frame: up to day 10 of each period
Pharmacokinetic parameter : Tmax
Time frame: up to day 10 of each period
Pharmacokinetic parameter : AUC
Time frame: up to day 10 of each period
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 1 Jun 2011.
- Derived from this study: PubMed 25150159Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.
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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.
Clinical Sciences & Operations study director
Sanofi
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 glargine HOE901 in people with Type 1 Diabetes Mellitus, 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 6 inclusion and 9 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 1 Jun 2011. 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?
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory (time frame: up to day 10 of each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349855, which also lists 1 linked publication.
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 1 Jun 2011.