Type1 DiabetesPhase 1NCT01838083
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin glargine new formulation HOE901 in people with Type1 Diabetes, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses Secondary Objective: To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- Insulin glargine new formulation HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Aug 2013
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
- Total insulin dose of < 1.2 U/kg/day
- Minimum usual basal insulin dose ≥ 0.2 U/kg/day
- Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
- Fasting negative serum C-peptide (< 0.3 nmol/L)
- Glycohemoglobin (HbA1c) ≤ 75 mmol/mol [≤ 9.0%]
Show all 10Show fewer
- Stable insulin regimen for at least 2 months prior to inclusion in study
- Certified as otherwise healthy for Type-1 Diabetes mellitus patient
- Laboratory parameters within the normal range
- Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status
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
- Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month)
- Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Show all 11Show fewer
- Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day)
- If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding
- 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 Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus
Primary Objective:
To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses
Secondary Objective:
- To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses
- To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations
Read the detailed description
Total study duration per subject: 29 to 64 days including screening visit
Duration of each part of the study for one subject:
- Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)
- Treatment Period 1 and 2: 8 days (dosing on 6 days)
- Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing
- Conditions
- Type1 Diabetes
- Being tested
- Insulin glargine new formulation HOE901
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargine new formulation HOE901Drug
Pharmaceutical form: solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine new formulation (test T formulation) | Experimental | Once daily for 6 days Receives: Drug: Insulin glargine new formulation HOE901 |
| Insulin glargine new formulation (reference R formulation) | Experimental | Once daily for 6 days Receives: Drug: Insulin glargine new formulation HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6
Measured: 24-hours (D6 to D7)
Secondary outcomes (9)
Maximum insulin concentration (INS-Cmax)
Measured: 24-hours (D6 to D7)
Time to INS-Cmax (INS-tmax)
Measured: 24-hours (D6 to D7)
Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)
Measured: 24-hours (D6 to D7)
Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp
Measured: 24-hours (D6 to D7)
Maximum smoothed body weight standardized glucose infusion rate (GIRmax)
Measured: 24-hours (D6 to D7)
Time to GIRmax (GIR-Tmax)
Measured: 24-hours (D6 to D7)
Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24)
Measured: 24-hours (D6 to D7)
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels)
Measured: 24-hours (D6 to D7)
Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies.
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 DiabetesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838083
- Sponsor's protocol ID
- PKD13560
- Other IDs
- 2012-005777-31, U1111-1139-3755
- Status last verified
- Aug 2013
- First submitted
- 16 Apr 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01838083
- Acronym / sponsor ID
- PKD13560
- Conditions
- Type1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Apr 2013 (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 demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses
Secondary Objective:
- To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses
- To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations
Detailed description
Total study duration per subject: 29 to 64 days including screening visit
Duration of each part of the study for one subject:
- Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)
- Treatment Period 1 and 2: 8 days (dosing on 6 days)
- Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine new formulation (test T formulation) | Experimental | Drug: Insulin glargine new formulation HOE901Once daily for 6 days |
| Insulin glargine new formulation (reference R formulation) | Experimental | Drug: Insulin glargine new formulation HOE901Once daily for 6 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
- Total insulin dose of < 1.2 U/kg/day
- Minimum usual basal insulin dose ≥ 0.2 U/kg/day
- Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
- Fasting negative serum C-peptide (< 0.3 nmol/L)
Key exclusion criteria (11 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
- Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month)
- Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
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 new formulation HOE901Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glargine new formulation (reference R formulation), Insulin glargine new formulation (test T formulation) |
Primary outcome
Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6
Time frame: 24-hours (D6 to D7)
9 secondary outcomes
Maximum insulin concentration (INS-Cmax)
Time frame: 24-hours (D6 to D7)
Time to INS-Cmax (INS-tmax)
Time frame: 24-hours (D6 to D7)
Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)
Time frame: 24-hours (D6 to D7)
Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp
Time frame: 24-hours (D6 to D7)
Maximum smoothed body weight standardized glucose infusion rate (GIRmax)
Time frame: 24-hours (D6 to D7)
Time to GIRmax (GIR-Tmax)
Time frame: 24-hours (D6 to D7)
Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24)
Time frame: 24-hours (D6 to D7)
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels)
Time frame: 24-hours (D6 to D7)
Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies.
Time frame: up to 9 weeks
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 13 Aug 2013.
Related trials for Type1 Diabetes
RecruitingObservational study
Exploration of Health Literacy in Diabetes in Reunion Island and France
Diabetes type1, Diabetes Type 2
Recruiting
Continuous Monitoring of Glycemic Variability to Predict Dys- and Hyperglycemia in Asymptomatic Type 1 Diabetes
Type1 Diabetes Mellitus
RecruitingPhase 2
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Diabetes type1, Obesity
Active, not recruitingPhase 2
Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes
Diabetes Mellitus, Type 1, Diabetes type1
Active, not recruitingPhase 2
Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years
Diabetes Mellitus, Type 1 Diabetes
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 new formulation HOE901 in people with Type1 Diabetes, 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 10 inclusion and 11 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 13 Aug 2013. 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?
Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6 (time frame: 24-hours (D6 to D7)). 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 13 Aug 2013; AzTrials last refreshed its copy on 1 Nov 2026.