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

August 3, 2015 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

54 weeks +/-11 days

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Adachi-Ku, Japan
        • Investigational Site Number 392335
      • Chiba-Shi, Japan
        • Investigational Site Number 392325
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392328
      • Chuo-Ku, Japan
        • Investigational Site Number 392326
      • Chuo-Ku, Japan
        • Investigational Site Number 392327
      • Chuoh-Ku, Japan
        • Investigational Site Number 392310
      • Kagoshima-Shi, Japan
        • Investigational Site Number 392336
      • Kamakura-Shi, Japan
        • Investigational Site Number 392314
      • Kashiwara-Shi, Japan
        • Investigational Site Number 392334
      • Kawagoe-Shi, Japan
        • Investigational Site Number 392304
      • Kawaguchi-Shi, Japan
        • Investigational Site Number 392306
      • Kisarazu-Shi, Japan
        • Investigational Site Number 392307
      • Koriyama-Shi, Japan
        • Investigational Site Number 392301
      • Mitaka-Shi, Japan
        • Investigational Site Number 392312
      • Mito-Shi, Japan
        • Investigational Site Number 392302
      • Mito-Shi, Japan
        • Investigational Site Number 392324
      • Nagoya-Shi, Japan
        • Investigational Site Number 392331
      • Nagoya-Shi, Japan
        • Investigational Site Number 392332
      • Ohta-Ku, Japan
        • Investigational Site Number 392329
      • Okawa-Shi, Japan
        • Investigational Site Number 392322
      • Osaka-Shi, Japan
        • Investigational Site Number 392333
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392330
      • Saijo-Shi, Japan
        • Investigational Site Number 392320
      • Sakado-Shi, Japan
        • Investigational Site Number 392303
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392311
      • Shizuoka-Shi, Japan
        • Investigational Site Number 392316
      • Suita-Shi, Japan
        • Investigational Site Number 392319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria :

  • 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

Exclusion criteria:

  • 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;

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lixisenatide + Biguanide
52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: biguanide
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + TZD
52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: TZD
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + alpha-GI
52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: alpha-GI
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + Glinide
52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: glinide
Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in HbA1c
Time Frame: From baseline to weeks 24 and 52
From baseline to weeks 24 and 52
Absolute change in fasting plasma glucose
Time Frame: From baseline to weeks 24 and 52
From baseline to weeks 24 and 52
Absolute change in body weight
Time Frame: From baseline to weeks 24 and 52
From baseline to weeks 24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS12809
  • U1111-1129-8754 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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