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Type 2 Diabetes MellitusPhase 3EDITION JP IINCT01689142

Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) in people with Type 2 Diabetes Mellitus, run by Sanofi at 31 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
31 sitesJapan
Study dates
Sep 2012to Jun 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

  • o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit;

Who cannot join

  • Age < 18 years at screening visit;
  • BMI(body mass index) ≥ 35 kg/m2 at screening visit;
  • HbA1c < 7.0% or > 10% (national glycohemoglobin standardization program [NGSP] value) at screening visit;
  • Diabetes other than type 2 diabetes mellitus;
  • Patients on self-monitoring of blood glucose less than 6 months before screening visit;
  • Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
Show all 12Show fewer
  • Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
  • Use of insulin pump in the last 6 months before screening visit;
  • Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
  • 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 (eg, 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

31 sites in 1 country.

31 sites in 1 country

Japan31 sites

  • Investigational Site Number 392226

    Amagasaki-Shi

  • Investigational Site Number 392218

    Chigasaki-Shi

  • Investigational Site Number 392212

    Chiyoda-Ku

  • Investigational Site Number 392208

    Chuoh-Ku

  • Investigational Site Number 392209

    Chūōku

  • Investigational Site Number 392210

    Chūōku

  • Investigational Site Number 392217

    Ebina-Shi

  • Investigational Site Number 392216

    Fujisawa-Shi

  • Investigational Site Number 392222

    Higashiosaka-Shi

  • Investigational Site Number 392223

    Izumisano

  • Investigational Site Number 392215

    Kamakura-Shi

  • Investigational Site Number 392225

    Kashiwara-Shi

  • Investigational Site Number 392205

    Kawagoe-Shi

  • Investigational Site Number 392204

    Kawaguchi-Shi

  • Investigational Site Number 392206

    Kisarazu-Shi

  • Investigational Site Number 392201

    Koriyama-Shi

  • Investigational Site Number 392228

    Kurashiki-Shi

  • Investigational Site Number 392229

    Matsuyama

  • Investigational Site Number 392230

    Matsuyama

  • Investigational Site Number 392211

    Mitaka-Shi

  • Investigational Site Number 392220

    Nagoya

  • Investigational Site Number 392227

    Nishinomiya-Shi

  • Investigational Site Number 392203

    Ogawa-Machi, Hikigun

  • Investigational Site Number 392231

    Okawa-Shi

  • Investigational Site Number 392224

    Osaka

  • Investigational Site Number 392207

    Shinjuku-Ku

  • Investigational Site Number 392219

    Shizuoka

  • Investigational Site Number 392221

    Takatsuki-Shi

  • Investigational Site Number 392202

    Ushiku-Shi

  • Investigational Site Number 392213

    Yokohama

  • Investigational Site Number 392214

    Yokohama

Other trials in Japan

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® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 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 2 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
Being tested
Insulin glargine new formulation (HOE901), Insulin glargine (HOE901)
Medical subject headings
Diabetes Mellitus, Type 2

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)Drug

    Also called Lantus

    Pharmaceutical form: solution Route of administration: subcutaneous

Study groups in NCT01689142
Study groupRoleWhat they receive
New formulation of insulin glargineExperimentalonce daily in the evening on-top of oral antihyperglycemic drug (OADs)
Receives: Drug: Insulin glargine new formulation (HOE901)
Lantus (insulin glargine)Active comparatoronce daily in the evening on-top of OADs
Receives: Drug: Insulin glargine (HOE901)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c

    Measured: baseline, 6 months

Secondary outcomes (8)

  1. Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)

    Measured: up to 6 months

  2. Change from baseline in FPG

    Measured: baseline, 6 months

  3. Change from baseline in pre-basal insulin injection SMPG

    Measured: baseline, 6 months

  4. Change from baseline in 8-point SMPG profiles

    Measured: baseline, 6 months

  5. Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)

    Measured: baseline, 6 months

  6. Change from baseline in variability of plasma glucose profile

    Measured: baseline, 6 months

  7. Change from baseline in daily basal insulin dose

    Measured: baseline, 6 months

  8. 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.

  1. First posted21 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionNov 2013
  4. Study completionJun 2014

Resources

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
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01689142
Sponsor's protocol ID
EFC12512
Other IDs
U1111-1130-3649
Acronym
EDITION JP II
Status last verified
Jun 2014
First submitted
14 Sep 2012
Last updated
5 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.

    PubMed 30160030

  • Terauchi Y, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016 Apr;18(4):366-74. doi: 10.1111/dom.12618. Epub 2016 Jan 21.

    PubMed 26662838

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) in people with Type 2 Diabetes Mellitus, run by Sanofi at 31 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 12 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 5 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 31 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 NCT01689142, which also lists 2 linked publications.

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 5 Jun 2014.

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