Type1 Diabetes MellitusPhase 1NCT02910518
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin glulisine (U300), Insulin glulisine and Insulin aspart in people with Type1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Insulin glulisine (U300), Insulin glulisine and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2017to 3 May 2017
- 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 with type 1 diabetes mellitus (T1DM) for more than 1 year.
- Total insulin dose of <1.2 U/kg/day.
- Fasting negative serum C-peptide (<0.30 nmol/L).
- Glycohemoglobin at screening (HbA1c) ≤9%.
- Subjects with anti-insulin antibody titer at screening ≤30.0 kU/L.
- Stable insulin regimen for at least 2 months prior to study.
- Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculoskeletal system), vital signs, electrocardiogram (ECG), and safety laboratory.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from T1DM), 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 or any history or presence of heparin induced thrombocytopenia Type II (HIT-type II).
- Severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
- 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 drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
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- Any medication (including medicine containing St John's Wort) within 14 days before inclusion (for systemic glucocorticoids within 3 months) or within 5 times the elimination half-life or PD half-life of the medication, with the exception of insulin, stable treatment (at least 2 months) with thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy.
- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- 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, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/mL) Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Primary Objective:
To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose.
Secondary Objectives:
- To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK) characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after a single SC dose.
- To assess safety and tolerability of the test and the reference formulation of insulin glulisine.
Read the detailed description
The study duration per patient will be 18 to 62 days and will consist of a 4 to 28 days of screening period, a treatment period of 2 days, a washout between dosing occasions of 5-18 days, and follow up visit 7-14 days after last dosing.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- Insulin glulisine (U300), Insulin glulisine, Insulin aspart, NPH insulin, Glucagon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisine (U300)Drug
Also called HMR1964 (U300)
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin glulisineDrug
Also called Apidra®
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin aspartDrug
Also called NovoRapid®
Pharmaceutical form: solution
Route of administration: intravenous/subcutaneous
NPH insulinDrug
Also called Insuman® Basal Solostar®
Pharmaceutical form: solution
Route of administration: subcutaneous
GlucagonDrug
Also called GlucaGen® HypoKit
Pharmaceutical form: Powder and solvent for solution for injection
Route of administration: subcutaneous
GlucoseDrug
Also called Glucose 20%
Pharmaceutical form: solution
Route of administration: intravenous
HeparinDrug
Also called Heparin-Natrium-5000
Pharmaceutical form: solution
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Insulin glulisine (U300) - Test formulation | Experimental | Insulin glulisine (U300) will be given as a single subcutaneous (SC) dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. Receives: Drug: Insulin glulisine (U300); Drug: Insulin aspart; Drug: NPH insulin; Drug: Glucagon; Drug: Glucose; Drug: Heparin |
| Insulin glulisine - Reference formulation | Active comparator | Insulin glulisine (U100) will be given as a single SC dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. Receives: Drug: Insulin glulisine; Drug: Insulin aspart; Drug: NPH insulin; Drug: Glucagon; Drug: Glucose; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PK parameter: maximum observed insulin concentration
Measured: 10 hours
Assessment of PK parameter: area under the concentration time curve
Measured: 10 hours
Secondary outcomes (7)
Assessment of PK parameter: time to reach Cmax (INS-tmax)
Measured: 10 hours
Assessment of PK parameter: terminal half-life (INS-t1/2z)
Measured: 10 hours
Assessment of PD parameter: area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 10 hours (GIR-AUC0-10)
Measured: 10 hours
Assessment of PD parameter: maximum smoothed body weight standardized GIR (GIRmax)
Measured: 10 hours
Assessment of PD parameter: time to GIRmax (GIR-tmax)
Measured: 10 hours
Duration of blood glucose control under clamp conditions - time
Measured: 10 hours
Number of patients with treatment emergent adverse events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start17 Feb 2017
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 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
- 44 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
- NCT02910518
- Sponsor's protocol ID
- BEQ13941
- Other IDs
- 2016-001498-34, U1111-1183-8636, 2016
- Status last verified
- Apr 2022
- First submitted
- 20 Sep 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/mL) Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02910518
- Acronym / sponsor ID
- BEQ13941
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 22 Sep 2016 (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 bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose.
Secondary Objectives:
- To assess the pharmacodynamic (PD) profiles and further pharmacokinetic (PK) characteristics of insulin glulisine U300 in comparison to insulin glulisine U100 after a single SC dose.
- To assess safety and tolerability of the test and the reference formulation of insulin glulisine.
Detailed description
The study duration per patient will be 18 to 62 days and will consist of a 4 to 28 days of screening period, a treatment period of 2 days, a washout between dosing occasions of 5-18 days, and follow up visit 7-14 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 glulisine (U300) - Test formulation | Experimental | Drug: Insulin glulisine (U300), Drug: Insulin aspart, Drug: NPH insulin, Drug: Glucagon, Drug: Glucose, Drug: HeparinInsulin glulisine (U300) will be given as a single subcutaneous (SC) dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
| Insulin glulisine - Reference formulation | Active comparator | Drug: Insulin glulisine, Drug: Insulin aspart, Drug: NPH insulin, Drug: Glucagon, Drug: Glucose, Drug: HeparinInsulin glulisine (U100) will be given as a single SC dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects with type 1 diabetes mellitus (T1DM) for more than 1 year.
- Total insulin dose of <1.2 U/kg/day.
- Fasting negative serum C-peptide (<0.30 nmol/L).
- Glycohemoglobin at screening (HbA1c) ≤9%.
- Subjects with anti-insulin antibody titer at screening ≤30.0 kU/L.
Key exclusion criteria (9 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from T1DM), 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 or any history or presence of heparin induced thrombocytopenia Type II (HIT-type II).
- Severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
- 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 drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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 (U300)Also: HMR1964 (U300)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glulisine (U300) - Test formulation |
| Insulin glulisineAlso: Apidra®Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glulisine - Reference formulation |
| Insulin aspartAlso: NovoRapid®Pharmaceutical form: solution Route of administration: intravenous/subcutaneous | Drug | Insulin glulisine (U300) - Test formulation, Insulin glulisine - Reference formulation |
| NPH insulinAlso: Insuman® Basal Solostar®Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Insulin glulisine (U300) - Test formulation, Insulin glulisine - Reference formulation |
| GlucagonAlso: GlucaGen® HypoKitPharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous | Drug | Insulin glulisine (U300) - Test formulation, Insulin glulisine - Reference formulation |
| GlucoseAlso: Glucose 20%Pharmaceutical form: solution Route of administration: intravenous | Drug | Insulin glulisine (U300) - Test formulation, Insulin glulisine - Reference formulation |
| HeparinAlso: Heparin-Natrium-5000Pharmaceutical form: solution Route of administration: intravenous | Drug | Insulin glulisine (U300) - Test formulation, Insulin glulisine - Reference formulation |
Primary outcome
Assessment of PK parameter: maximum observed insulin concentration
Time frame: 10 hours
Assessment of PK parameter: area under the concentration time curve
Time frame: 10 hours
7 secondary outcomes
Assessment of PK parameter: time to reach Cmax (INS-tmax)
Time frame: 10 hours
Assessment of PK parameter: terminal half-life (INS-t1/2z)
Time frame: 10 hours
Assessment of PD parameter: area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 10 hours (GIR-AUC0-10)
Time frame: 10 hours
Assessment of PD parameter: maximum smoothed body weight standardized GIR (GIRmax)
Time frame: 10 hours
Assessment of PD parameter: time to GIRmax (GIR-tmax)
Time frame: 10 hours
Duration of blood glucose control under clamp conditions - time
Time frame: 10 hours
Number of patients with treatment emergent adverse events
Time frame: 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 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 glulisine (U300), Insulin glulisine and Insulin aspart in people with Type1 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 7 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 25 Apr 2022. 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?
Assessment of PK parameter: maximum observed insulin concentration (time frame: 10 hours). 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 25 Apr 2022.