Type 1 Diabetes MellitusPhase 3EDITION JP INCT01689129
Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
A Phase 3 study testing Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) (Lantus) in people with Type 1 Diabetes Mellitus, run by Sanofi at 22 sites in Japan.
Trial summary
Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) (Lantus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 22 sitesJapan
- Study dates
- Sep 2012to Apr 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 1 diabetes mellitus
Who cannot join
- Age < 18 years at screening visit;
- HbA1c < 7.0 % or > 10.0 % (national glycohemoglobin standardization program [NGSP] value) at screening visit;
- Patients less than 1 year before screening visit on any basal plus mealtime insulin;
- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;
- Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;
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- Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eq, laser, surgical treatment or injectable drugs) during the study period.
- 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
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Investigational Site Number 392119
Amagasaki-Shi
Investigational Site Number 392106
Chūōku
Investigational Site Number 392107
Chūōku
Investigational Site Number 392110
Ebina-Shi
Investigational Site Number 392115
Higashiosaka-Shi
Investigational Site Number 392117
Izumisano
Investigational Site Number 392109
Kamakura-Shi
Investigational Site Number 392101
Koriyama-Shi
Investigational Site Number 392121
Kurashiki-Shi
Investigational Site Number 392112
Nagoya
Investigational Site Number 392120
Nishinomiya-Shi
Investigational Site Number 392113
Osaka
Investigational Site Number 392116
Osaka
Investigational Site Number 392118
Osaka
Investigational Site Number 392104
Shinjuku-Ku
Investigational Site Number 392105
Shinjuku-Ku
Investigational Site Number 392111
Shizuoka
Investigational Site Number 392114
Takatsuki-Shi
Investigational Site Number 392122
Tokushima
Investigational Site Number 392103
Tomioka-Shi
Investigational Site Number 392102
Ushiku-Shi
Investigational Site Number 392108
Yokohama
About this study
Official title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Read the detailed description
The duration of study will consist of:
- Up to 2-week screening period;
- 6-month open-label comparative efficacy and safety treatment period;
- 6-month open-label comparative safety extension period;
- 4-week post-treatment safety follow-up period
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glargine new formulation (HOE901), Insulin glargine (HOE901) (Lantus)
- 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 new formulation (HOE901)Drug
Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine (HOE901) (Lantus)Drug
Also called Lantus
Pharmaceutical form: solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| New formulation of insulin glargine | Experimental | once daily in the evening on-top of mealtime insulin Receives: Drug: Insulin glargine new formulation (HOE901) |
| Lantus (insulin glargine) | Active comparator | once daily in the evening on-top of mealtime insulin Receives: Drug: Insulin glargine (HOE901) (Lantus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: baseline, 6 months
Secondary outcomes (8)
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Measured: up to 6 months
Change from baseline in FPG
Measured: baseline, 6 months
Change from baseline in pre-basal insulin injection SMPG
Measured: baseline, 6 months
Change from baseline in 8-point SMPG profiles
Measured: baseline, 6 months
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Measured: baseline, 6 months
Change from baseline in variability of plasma glucose profile
Measured: baseline, 6 months
Change from baseline in daily basal insulin dose
Measured: baseline, 6 months
Number of Patients with various types of Hypoglycemia Events
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 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
- NCT01689129
- Sponsor's protocol ID
- EFC12449
- Other IDs
- U1111-1130-3513
- Acronym
- EDITION JP I
- Status last verified
- Jun 2014
- First submitted
- 14 Sep 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.
PubMed 26662964
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
- ClinicalTrials.gov ID
- NCT01689129
- Acronym / sponsor ID
- EDITION JP I / EFC12449
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Sep 2012 (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 efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 1 diabetes mellitus
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Detailed description
The duration of study will consist of:
- Up to 2-week screening period;
- 6-month open-label comparative efficacy and safety treatment period;
- 6-month open-label comparative safety extension period;
- 4-week post-treatment safety follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New formulation of insulin glargine | Experimental | Drug: Insulin glargine new formulation (HOE901)once daily in the evening on-top of mealtime insulin |
| Lantus (insulin glargine) | Active comparator | Drug: Insulin glargine (HOE901) (Lantus)once daily in the evening on-top of mealtime insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 1 diabetes mellitus
Key exclusion criteria (9 listed)
- Age < 18 years at screening visit;
- HbA1c < 7.0 % or > 10.0 % (national glycohemoglobin standardization program [NGSP] value) at screening visit;
- Patients less than 1 year before screening visit on any basal plus mealtime insulin;
- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;
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 (HOE901)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | New formulation of insulin glargine |
| Insulin glargine (HOE901) (Lantus)Also: LantusPharmaceutical form: solution Route of administration: subcutaneous | Drug | Lantus (insulin glargine) |
Primary outcome
Change from baseline in HbA1c
Time frame: baseline, 6 months
8 secondary outcomes
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Time frame: up to 6 months
Change from baseline in FPG
Time frame: baseline, 6 months
Change from baseline in pre-basal insulin injection SMPG
Time frame: baseline, 6 months
Change from baseline in 8-point SMPG profiles
Time frame: baseline, 6 months
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Time frame: baseline, 6 months
Change from baseline in variability of plasma glucose profile
Time frame: baseline, 6 months
Change from baseline in daily basal insulin dose
Time frame: baseline, 6 months
Number of Patients with various types of Hypoglycemia Events
Time frame: up to 6 months
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 9 Jun 2014.
- Derived from this study: PubMed 26662964Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.
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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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) (Lantus) in people with Type 1 Diabetes Mellitus, run by Sanofi at 22 sites 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 1 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in HbA1c (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689129, which also lists 1 linked publication.
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 9 Jun 2014.