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

NCT ID: NCT01940965

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-07-31

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.

Detailed Description

54 weeks +/-11 days

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lixisenatide + Biguanide

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

Group Type: EXPERIMENTAL

lixisenatide AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

biguanide

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + TZD

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

Group Type: EXPERIMENTAL

lixisenatide AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

TZD

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + alpha-GI

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

Group Type: EXPERIMENTAL

lixisenatide AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

alpha-GI

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Lixisenatide + Glinide

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

Group Type: EXPERIMENTAL

lixisenatide AVE0010

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

glinide

Intervention Type: DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

lixisenatide AVE0010

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Intervention Type: DRUG

biguanide

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

TZD

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

alpha-GI

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

glinide

Pharmaceutical form:tablet Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392335

Adachi-Ku, , Japan

Investigational Site Number 392325

Chiba, , Japan

Investigational Site Number 392328

Chiyoda-Ku, , Japan

Investigational Site Number 392310

Chuoh-Ku, , Japan

Investigational Site Number 392326

Chūōku, , Japan

Investigational Site Number 392327

Chūōku, , Japan

Investigational Site Number 392336

Kagoshima, , Japan

Investigational Site Number 392314

Kamakura-Shi, , Japan

Investigational Site Number 392334

Kashiwara-Shi, , Japan

Investigational Site Number 392304

Kawagoe-Shi, , Japan

Investigational Site Number 392306

Kawaguchi-Shi, , Japan

Investigational Site Number 392307

Kisarazu-Shi, , Japan

Investigational Site Number 392301

Koriyama-Shi, , Japan

Investigational Site Number 392312

Mitaka-Shi, , Japan

Investigational Site Number 392302

Mito, , Japan

Investigational Site Number 392324

Mito, , Japan

Investigational Site Number 392331

Nagoya, , Japan

Investigational Site Number 392332

Nagoya, , Japan

Investigational Site Number 392329

Ohta-Ku, , Japan

Investigational Site Number 392322

Okawa-Shi, , Japan

Investigational Site Number 392333

Osaka, , Japan

Investigational Site Number 392330

Sagamihara-Shi, , Japan

Investigational Site Number 392320

Saijo-Shi, , Japan

Investigational Site Number 392303

Sakado-Shi, , Japan

Investigational Site Number 392311

Shinjuku-Ku, , Japan

Investigational Site Number 392316

Shizuoka, , Japan

Investigational Site Number 392319

Suita-Shi, , Japan

Countries

Japan

Other Identifiers

U1111-1129-8754

Identifier Type: OTHER

Identifier Source: secondary_id

LTS12809

Identifier Type: -

Identifier Source: org_study_id