Type 1 Diabetes MellitusPhase 1/2NCT01053728
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
A Phase 1/2 study testing SAR161271 and Insulin glargine HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM. Secondary Objective: To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- SAR161271 and Insulin glargine HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Nov 2010
- Phase
- Phase 1/2
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of <1.2 U/kg/day
- Fasting negative serum C-peptide (<0.3 nmol/L)
- Glycated hemoglobin (HbA1c) < or = 9%
- Stable insulin regimen for at least 2 months before the study
- Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
- Certified as healthy for T1DM by a comprehensive clinical assessment
Who cannot join
- Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
- Blood donation, any volume, within 1 month before inclusion.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
- 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: Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus
Primary Objective:
- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
Secondary Objective:
- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
Read the detailed description
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:
- Screening: 3 to 27 days;
- Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
- Wash-out between doses: 7 to 10 days;
- End of Study visit: 7 to 10 days after last dose.
- Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- SAR161271, 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.
SAR161271Drug
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
Insulin glargine HOE901Drug
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : SAR161271 0.3 U/kg | Experimental | Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp Receives: Drug: SAR161271; Drug: Insulin glargine HOE901 |
| Cohort 2 : SAR161271 0.6 U/kg | Experimental | Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp Receives: Drug: SAR161271; Drug: Insulin glargine HOE901 |
| Cohort 3 : SAR161271 1.2 U/kg | Experimental | Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp Receives: Drug: SAR161271; 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 for each cohort
Measured: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
Measured: up to 30 hours after dose
Secondary outcomes (2)
- Pharmacokinetic parameters
Measured: up to 168 hours after dose
- anti-insulin antibody production
Measured: pre-dose and after 4th dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionNov 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
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
- NCT01053728
- Sponsor's protocol ID
- TDU10987
- Other IDs
- TDU10948
- Status last verified
- Jul 2011
- First submitted
- 19 Jan 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01053728
- Acronym / sponsor ID
- TDU10987
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Jan 2010 (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 establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
Secondary Objective:
- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
Detailed description
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:
- Screening: 3 to 27 days;
- Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
- Wash-out between doses: 7 to 10 days;
- End of Study visit: 7 to 10 days after last dose.
- Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : SAR161271 0.3 U/kg | Experimental | Drug: SAR161271, Drug: Insulin glargine HOE901Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 2 : SAR161271 0.6 U/kg | Experimental | Drug: SAR161271, Drug: Insulin glargine HOE901Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
| Cohort 3 : SAR161271 1.2 U/kg | Experimental | Drug: SAR161271, Drug: Insulin glargine HOE901Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of <1.2 U/kg/day
- Fasting negative serum C-peptide (<0.3 nmol/L)
- Glycated hemoglobin (HbA1c) < or = 9%
- Stable insulin regimen for at least 2 months before the study
- Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
Key exclusion criteria (6 listed)
- Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
- Blood donation, any volume, within 1 month before inclusion.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
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 |
|---|---|---|
| SAR161271Pharmaceutical form:Solution for injection Route of administration: subcutaneous | Drug | Cohort 1 : SAR161271 0.3 U/kg, Cohort 2 : SAR161271 0.6 U/kg, Cohort 3 : SAR161271 1.2 U/kg |
| Insulin glargine HOE901Pharmaceutical form:Solution for injection Route of administration: subcutaneous | Drug | Cohort 1 : SAR161271 0.3 U/kg, Cohort 2 : SAR161271 0.6 U/kg, Cohort 3 : SAR161271 1.2 U/kg |
Primary outcome
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
Time frame: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
Time frame: up to 30 hours after dose
2 secondary outcomes
- Pharmacokinetic parameters
Time frame: up to 168 hours after dose
- anti-insulin antibody production
Time frame: pre-dose and after 4th dose
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 26 Jul 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.
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 1/2 study testing SAR161271 and 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 6 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 26 Jul 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 for each cohort (time frame: up to 7 days after dose). 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 26 Jul 2011.