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Type 2 Diabetes MellitusPhase 3NCT01940965

Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

A Phase 3 study testing lixisenatide AVE0010, biguanide and TZD in people with Type 2 Diabetes Mellitus, run by Sanofi at 27 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: The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
lixisenatide AVE0010, biguanide and TZD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
27 sitesJapan
Study dates
Sep 2013to Jul 2015
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
  • Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label
  • a biguanide (metformin hydrochloride);
  • a thiazolidinedione (TZD) (pioglitazone hydrochloride);
  • an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);
  • or a glinide (nateglinide, repaglinide or mitiglinide);
  • Signed written informed consent

Who cannot join

  • At screening HbA1c <7% or >9.5%;
  • At screening: fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
  • Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
  • Type 1 diabetes mellitus;
  • Women of childbearing potential with no effective contraceptive method;
  • Pregnancy or lactation;
Show all 14Show fewer
  • Laboratory findings at the time of screening:
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);
  • ALT >3 ULN;
  • Any contra-indication to the patient's background oral anti-diabetic treatment;
  • History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
  • Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.
  • 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

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • Investigational Site Number 392335

    Adachi-Ku

  • Investigational Site Number 392325

    Chiba

  • Investigational Site Number 392328

    Chiyoda-Ku

  • Investigational Site Number 392310

    Chuoh-Ku

  • Investigational Site Number 392326

    Chūōku

  • Investigational Site Number 392327

    Chūōku

  • Investigational Site Number 392336

    Kagoshima

  • Investigational Site Number 392314

    Kamakura-Shi

  • Investigational Site Number 392334

    Kashiwara-Shi

  • Investigational Site Number 392304

    Kawagoe-Shi

  • Investigational Site Number 392306

    Kawaguchi-Shi

  • Investigational Site Number 392307

    Kisarazu-Shi

  • Investigational Site Number 392301

    Koriyama-Shi

  • Investigational Site Number 392312

    Mitaka-Shi

  • Investigational Site Number 392302

    Mito

  • Investigational Site Number 392324

    Mito

  • Investigational Site Number 392331

    Nagoya

  • Investigational Site Number 392332

    Nagoya

  • Investigational Site Number 392329

    Ohta-Ku

  • Investigational Site Number 392322

    Okawa-Shi

  • Investigational Site Number 392333

    Osaka

  • Investigational Site Number 392330

    Sagamihara-Shi

  • Investigational Site Number 392320

    Saijo-Shi

  • Investigational Site Number 392303

    Sakado-Shi

  • Investigational Site Number 392311

    Shinjuku-Ku

  • Investigational Site Number 392316

    Shizuoka

  • Investigational Site Number 392319

    Suita-Shi

Other trials in Japan

About this study

Official title: An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Primary Objective:

The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective:

To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:

  • HbA1c;
  • Fasting plasma glucose;
  • Body weight.
Read the detailed description

54 weeks +/-11 days

Being tested
lixisenatide AVE0010, biguanide, TZD, alpha-GI, glinide
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.

  • lixisenatide AVE0010Drug

    Pharmaceutical form:solution Route of administration: Subcutaneous injection

  • biguanideDrug

    Pharmaceutical form:tablet Route of administration: oral

  • TZDDrug

    Pharmaceutical form:tablet Route of administration: oral

  • alpha-GIDrug

    Pharmaceutical form:tablet Route of administration: oral

  • glinideDrug

    Pharmaceutical form:tablet Route of administration: oral

Study groups in NCT01940965
Study groupRoleWhat they receive
Lixisenatide + BiguanideExperimental52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Receives: Drug: lixisenatide AVE0010; Drug: biguanide
Lixisenatide + TZDExperimental52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Receives: Drug: lixisenatide AVE0010; Drug: TZD
Lixisenatide + alpha-GIExperimental52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Receives: Drug: lixisenatide AVE0010; Drug: alpha-GI
Lixisenatide + GlinideExperimental52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Receives: Drug: lixisenatide AVE0010; Drug: glinide

What is being measured

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

  1. Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data

    Measured: 52 weeks

Secondary outcomes (3)

  1. Absolute change in HbA1c

    Measured: From baseline to weeks 24 and 52

  2. Absolute change in fasting plasma glucose

    Measured: From baseline to weeks 24 and 52

  3. Absolute change in body weight

    Measured: From baseline to weeks 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940965
Sponsor's protocol ID
LTS12809
Other IDs
U1111-1129-8754
Status last verified
Aug 2015
First submitted
9 Sep 2013
Last updated
4 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lixisenatide AVE0010, biguanide and TZD in people with Type 2 Diabetes Mellitus, run by Sanofi at 27 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 7 inclusion and 14 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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?

Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data (time frame: 52 weeks). 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 NCT01940965.

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 4 Aug 2015.

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