Type 1 Diabetes MellitusPhase 1NCT02201199
Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
A Phase 1 study testing insulin glargine U200 HOE901, insulin glargine U500 HOE901 and insulin glargine U100 HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes. 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 U200 HOE901, insulin glargine U500 HOE901 and insulin glargine U100 HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Nov 2014
- 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 type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association.
- Total insulin dose <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%).
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- Stable insulin regimen for at least 2 months prior to inclusion in study.
- Certified as otherwise healthy for Type 1 diabetes mellitus patient.
- Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- 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).
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment.
- Presence or history of drug or alcohol abuse (alcohol consumption >40 grams / day).
- Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.
- Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication in the last month before study start with the exception of insulin products, 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; any biologics (antibody or its derivatives) given within 4 months before randomization.
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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 Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes
Primary Objective:
To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
Secondary Objectives:
To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.
Read the detailed description
Total study duration for each subject is between 3.5 and 12 weeks.
Two overnight stays at the unit in each of 3 treatment periods.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- insulin glargine U200 HOE901, insulin glargine U500 HOE901, insulin glargine U100 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 U200 HOE901Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
insulin glargine U500 HOE901Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
insulin glargine U100 HOE901Drug
Also called Lantus
Pharmaceutical form:solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine U100 | Active comparator | 1 single dose Receives: Drug: insulin glargine U100 HOE901 |
| insulin glargine U200 | Experimental | 1 single dose Receives: Drug: insulin glargine U200 HOE901 |
| insulin glargine U500 | Experimental | 1 single dose Receives: Drug: insulin glargine U500 HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
Measured: 12 hours
Secondary outcomes (9)
INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)
Measured: 36 hours
AUC up to the last measurable concentration
Measured: 36 hours
Time to reach 50% of INS-AUC 0-36
Measured: 36 hours
Time to reach INS-Cmax (INS-tmax)
Measured: 36 hours
Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)
Measured: 36 hours
Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)
Measured: 36 hours
Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)
Measured: 36 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)
Measured: 4 days
Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT02201199
- Sponsor's protocol ID
- PDY13928
- Other IDs
- 2014-001252-33, U1111-1153-3712, 2014
- Status last verified
- Dec 2014
- First submitted
- 24 Jul 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02201199
- Acronym / sponsor ID
- PDY13928
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Jul 2014 (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 compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
Secondary Objectives:
To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.
To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.
Detailed description
Total study duration for each subject is between 3.5 and 12 weeks.
Two overnight stays at the unit in each of 3 treatment periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| insulin glargine U100 | Active comparator | Drug: insulin glargine U100 HOE9011 single dose |
| insulin glargine U200 | Experimental | Drug: insulin glargine U200 HOE9011 single dose |
| insulin glargine U500 | Experimental | Drug: insulin glargine U500 HOE9011 single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association.
- Total insulin dose <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 (9 listed)
- 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).
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment.
- Presence or history of drug or alcohol abuse (alcohol consumption >40 grams / day).
- Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.
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 U200 HOE901Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | insulin glargine U200 |
| insulin glargine U500 HOE901Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | insulin glargine U500 |
| insulin glargine U100 HOE901Also: LantusPharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | insulin glargine U100 |
Primary outcome
Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing
Time frame: 12 hours
9 secondary outcomes
INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)
Time frame: 36 hours
AUC up to the last measurable concentration
Time frame: 36 hours
Time to reach 50% of INS-AUC 0-36
Time frame: 36 hours
Time to reach INS-Cmax (INS-tmax)
Time frame: 36 hours
Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)
Time frame: 36 hours
Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)
Time frame: 36 hours
Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)
Time frame: 36 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)
Time frame: 4 days
Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)
Time frame: 4 days
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 Dec 2014.
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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 U200 HOE901, insulin glargine U500 HOE901 and insulin glargine U100 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 10 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 24 Dec 2014. 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 glargine (INS) concentration curve over the first 12 hours after dosing (time frame: 12 hours). 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 Dec 2014.