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Type 2 Diabetes MellitusPhase 3EDITION APNCT02855684

Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

A Phase 3 study testing Insulin glargine (U300), Insulin glargine and Non-insulin antihyperglycemic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 54 sites in 3 countries.

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 insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in 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 (U300), Insulin glargine and Non-insulin antihyperglycemic drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
604 participants
Where
54 sitesin 3 countries
Study dates
24 Aug 2016to 6 Aug 2018
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

  • Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s).
  • Signed written informed consent.

Who cannot join

  • Age < legal age of adulthood.
  • HbA1c <7.0% (<53 mmol/mol) or >11% (>97 mmol/mol) (at screening).
  • History of type 2 diabetes mellitus for less than 1 year before screening.
  • Less than 6 months before screening with non-insulin antihyperglycemic treatment.
  • Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening.
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit.
Show all 11Show fewer
  • Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization).
  • Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening.
  • 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

54 sites in 3 countries.

54 sites in 3 countries

China39 sites

  • Investigational Site Number 1560039

    Beijing, 100034

  • Investigational Site Number 1560001

    Beijing, 100044

  • Investigational Site Number 1560017

    Beijing, 100191

  • Investigational Site Number 1560003

    Beijing, 100730

  • Investigational Site Number 1560033

    Changchun, 130021

  • Investigational Site Number 1560016

    Changzhou, 213003

  • Investigational Site Number 1560049

    Changzhou, 213003

  • Investigational Site Number 1560006

    Fuzhou, 354200

  • Investigational Site Number 1560004

    Guangzhou, 510080

  • Investigational Site Number 1560036

    Guangzhou, 510080

  • Investigational Site Number 1560043

    Guangzhou, 510120

  • Investigational Site Number 1560014

    Guangzhou, 510515

  • Investigational Site Number 1560042

    Guiyang, 550004

  • Investigational Site Number 1560024

    Hangzhou, 310015

  • Investigational Site Number 1560046

    Hefei, 230001

  • Investigational Site Number 1560025

    Hohhot, 010017

  • Investigational Site Number 1560019

    Jinan, 250013

  • Investigational Site Number 1560027

    Lanzhou, 730000

  • Investigational Site Number 1560038

    Nanchang, 330006

  • Investigational Site Number 1560045

    Nanchang, 330006

  • Investigational Site Number 1560002

    Nanjing, 210008

  • Investigational Site Number 1560012

    Nanjing, 210011

  • Investigational Site Number 1560047

    Nanjing, 210029

  • Investigational Site Number 1560021

    Shanghai, 200040

  • Investigational Site Number 1560018

    Shanghai, 200240

  • Investigational Site Number 1560048

    Shenyang, 110004

  • Investigational Site Number 1560005

    Shenyang, 110022

  • Investigational Site Number 1560020

    Shenzhen, 518036

  • Investigational Site Number 1560013

    Siping, 136000

  • Investigational Site Number 1560031

    Tangshan, 063000

  • Investigational Site Number 1560023

    Tianjin, 300052

  • Investigational Site Number 1560044

    Tianjin, 300121

  • Investigational Site Number 1560009

    Xi'an, 710061

  • Investigational Site Number 1560034

    Xiamen, 361003

  • Investigational Site Number 1560010

    Xuzhou, 221002

  • Investigational Site Number 1560026

    Yueyang, 414000

  • Investigational Site Number 1560011

    Zhengzhou, 450052

  • Investigational Site Number 1560030

    Zhenjiang, 212001

  • Investigational Site Number 1560041

    Zhuzhou, 412007

Other trials in China

South Korea11 sites

  • Investigational Site Number 4100003

    Anyang, 431-070

  • Investigational Site Number 4100005

    Busan, 602-739

  • Investigational Site Number 4100010

    Gwangju, 61453

  • Investigational Site Number 4100012

    Gyeonggi-do, 11923

  • Investigational Site Number 4100008

    Seoul, 01830

  • Investigational Site Number 4100001

    Seoul, 03181

  • Investigational Site Number 4100009

    Seoul, 06351

  • Investigational Site Number 4100004

    Seoul, 110-744

  • Investigational Site Number 4100006

    Seoul, 120-752

  • Investigational Site Number 4100007

    Seoul, 138-878

  • Investigational Site Number 4100002

    Wŏnju, 26426

Other trials in South Korea

Taiwan4 sites

  • Investigational Site Number 1580001

    Taichung, 40447

  • Investigational Site Number 1580004

    Taipei, 104

  • Investigational Site Number 1580003

    Taipei, 11031

  • Investigational Site Number 1580002

    Taipei, 220

Other trials in Taiwan

About this study

Official title: 6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs

Primary Objective:

To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus.

Read more

Secondary Objectives:

  • To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia.
  • To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia).
  • To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia).
  • To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative).
  • To assess the safety and tolerability of insulin glargine (U300).
  • To assess the development of anti-insulin glargine antibodies (AIA).
Read the detailed description

The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Being tested
Insulin glargine (U300), Insulin glargine, Non-insulin antihyperglycemic drugs
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 (U300)Drug

    Also called HOE901; Toujeo

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Insulin glargineDrug

    Also called HOE901; Lantus

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Non-insulin antihyperglycemic drugsDrug

    Also called Non-insulin antihyperglycemic therapy

    Pharmaceutical form: capsule/tablet

    Route of administration: oral

Study groups in NCT02855684
Study groupRoleWhat they receive
Toujeo - insulin glargine (U300)ExperimentalToujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Receives: Drug: Insulin glargine (U300); Drug: Non-insulin antihyperglycemic drugs
Lantus - insulin glargineActive comparatorLantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Receives: Drug: Insulin glargine; Drug: Non-insulin antihyperglycemic drugs

What is being measured

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

  1. Change in HbA1c from baseline

    Measured: Baseline, 6 months

Secondary outcomes (12)

  1. Percentage (%) of patients with at least one hypoglycemia

    Measured: Baseline, up to 6 months

  2. Percentage (%) of patients with at least one nocturnal hypoglycemia

    Measured: Baseline, up to 6 months

  3. Percentage (%) of patients with HbA1c <7.0%

    Measured: 6 months

  4. Percentage (%) of patients with HbA1c ≤6.5%

    Measured: 6 months

  5. Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)

    Measured: 6 months

  6. Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)

    Measured: 6 months

  7. Percentage (%) of patients requiring rescue therapy

    Measured: 6 months

  8. Change in fasting plasma glucose

    Measured: Baseline, 6 months

  9. Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles

    Measured: Baseline, 6 months

  10. Change of mean 24-hour plasma glucose

    Measured: Baseline, 6 months

  11. Change in variability of plasma glucose profile

    Measured: Baseline, 6 months

  12. Change in daily basal insulin dose

    Measured: Baseline, 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 posted4 Aug 2016 (estimated)
  2. Study start24 Aug 2016
  3. Primary completion6 Aug 2018
  4. Study completion6 Aug 2018

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
604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855684
Sponsor's protocol ID
EFC12814
Other IDs
U1111-1139-3894
Acronym
EDITION AP
Status last verified
Apr 2022
First submitted
2 Aug 2016
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine (U300), Insulin glargine and Non-insulin antihyperglycemic drugs in people with Type 2 Diabetes Mellitus, run by Sanofi at 54 sites in 3 countries.

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 2 inclusion and 11 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 54 sites in China, South Korea, Taiwan. 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 in HbA1c from baseline (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 NCT02855684.

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.

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