NCT01940965

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

  • HbA1c;
  • Fasting plasma glucose;
  • Body weight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2013

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

September 9, 2013

Last Update Submit

August 3, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

    52 weeks

Secondary Outcomes (3)

  • Absolute change in HbA1c

    From baseline to weeks 24 and 52

  • Absolute change in fasting plasma glucose

    From baseline to weeks 24 and 52

  • Absolute change in body weight

    From baseline to weeks 24 and 52

Study Arms (4)

Lixisenatide + Biguanide

EXPERIMENTAL

52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)

Drug: lixisenatide AVE0010Drug: biguanide

Lixisenatide + TZD

EXPERIMENTAL

52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)

Drug: lixisenatide AVE0010Drug: TZD

Lixisenatide + alpha-GI

EXPERIMENTAL

52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)

Drug: lixisenatide AVE0010Drug: alpha-GI

Lixisenatide + Glinide

EXPERIMENTAL

52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)

Drug: lixisenatide AVE0010Drug: glinide

Interventions

lixisenatide AVE0010DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Lixisenatide + BiguanideLixisenatide + GlinideLixisenatide + TZDLixisenatide + alpha-GI
biguanideDRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + Biguanide
TZDDRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + TZD
alpha-GIDRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + alpha-GI
glinideDRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + Glinide

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • At screening HbA1c \<7% or \>9.5%;
  • At screening: fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Investigational Site Number 392335

Adachi-Ku, Japan

Location

Investigational Site Number 392325

Chiba, Japan

Location

Investigational Site Number 392328

Chiyoda-Ku, Japan

Location

Investigational Site Number 392310

Chuoh-Ku, Japan

Location

Investigational Site Number 392326

Chūōku, Japan

Location

Investigational Site Number 392327

Chūōku, Japan

Location

Investigational Site Number 392336

Kagoshima, Japan

Location

Investigational Site Number 392314

Kamakura-Shi, Japan

Location

Investigational Site Number 392334

Kashiwara-Shi, Japan

Location

Investigational Site Number 392304

Kawagoe-Shi, Japan

Location

Investigational Site Number 392306

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392307

Kisarazu-Shi, Japan

Location

Investigational Site Number 392301

Koriyama-Shi, Japan

Location

Investigational Site Number 392312

Mitaka-Shi, Japan

Location

Investigational Site Number 392302

Mito, Japan

Location

Investigational Site Number 392324

Mito, Japan

Location

Investigational Site Number 392331

Nagoya, Japan

Location

Investigational Site Number 392332

Nagoya, Japan

Location

Investigational Site Number 392329

Ohta-Ku, Japan

Location

Investigational Site Number 392322

Okawa-Shi, Japan

Location

Investigational Site Number 392333

Osaka, Japan

Location

Investigational Site Number 392330

Sagamihara-Shi, Japan

Location

Investigational Site Number 392320

Saijo-Shi, Japan

Location

Investigational Site Number 392303

Sakado-Shi, Japan

Location

Investigational Site Number 392311

Shinjuku-Ku, Japan

Location

Investigational Site Number 392316

Shizuoka, Japan

Location

Investigational Site Number 392319

Suita-Shi, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatideBiguanidesconotoxin GI

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic Chemicals

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

JP(27)