Type 1 Diabetes MellitusPhase 1NCT01493115
Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
A Phase 1 study testing Insulin glargine HOE901 and Insulin glargine - New formulation HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® Secondary Objective: To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glargine HOE901 and 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
- 18 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Apr 2012
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society
- Body weight between 50.0 kg and 95.0 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 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 4 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, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique
Primary Objective:
To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®
Secondary Objective:
To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation
Read the detailed description
The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glargine HOE901, Insulin glargine - New formulation 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
Also called Lantus®
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Insulin glargine - New formulation HOE901Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) Receives: Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901 |
| Sequence 2 | Experimental | Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) Receives: Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901 |
| Sequence 3 | Experimental | Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) Receives: Drug: Insulin glargine HOE901; Drug: Insulin glargine - New formulation HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose infusion rate
Measured: up to day 2 of each period
Secondary outcomes (5)
Pharmacokinetic parameter : Cmax
Measured: up to day 2 of each period
Pharmacokinetic parameter : Tmax
Measured: up to day 2 of each period
Pharmacokinetic parameter : AUC
Measured: up to day 2 of each period
Number of patients with adverse events
Measured: up to day 3 of each period
Safety-related parameters including electrocardiogram, vital signs and laboratory tests
Measured: up to day 3 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 posted15 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT01493115
- Sponsor's protocol ID
- PKD12270
- Other IDs
- U1111-1120-0463
- Status last verified
- Apr 2012
- First submitted
- 29 Nov 2011
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique
- ClinicalTrials.gov ID
- NCT01493115
- Acronym / sponsor ID
- PKD12270
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Dec 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 compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®
Secondary Objective:
To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation
Detailed description
The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Insulin glargine HOE901, Drug: Insulin glargine - New formulation HOE901Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) |
| Sequence 2 | Experimental | Drug: Insulin glargine HOE901, Drug: Insulin glargine - New formulation HOE901Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) |
| Sequence 3 | Experimental | Drug: Insulin glargine HOE901, Drug: Insulin glargine - New formulation HOE901Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society
- Body weight between 50.0 kg and 95.0 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 4 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 HOE901Also: Lantus®Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Sequence 1, Sequence 2, Sequence 3 |
| Insulin glargine - New formulation HOE901Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Glucose infusion rate
Time frame: up to day 2 of each period
5 secondary outcomes
Pharmacokinetic parameter : Cmax
Time frame: up to day 2 of each period
Pharmacokinetic parameter : Tmax
Time frame: up to day 2 of each period
Pharmacokinetic parameter : AUC
Time frame: up to day 2 of each period
Number of patients with adverse events
Time frame: up to day 3 of each period
Safety-related parameters including electrocardiogram, vital signs and laboratory tests
Time frame: up to day 3 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 May 2012.
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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 and Insulin glargine - New formulation HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
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 May 2012. 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 Japan. 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?
Glucose infusion rate (time frame: up to day 2 of each period). 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 1 May 2012.