DRUG
LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous
Status
Completed
Phase
Phase 4
Enrollment
136
Locations
20
Results
Not posted
Publications
1
Study summary
Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: * Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast * Delaying gastric emptying (13C-acetic acid breath test) * Safety and tolerability
The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances. 13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).
Interventions
DRUG
Pharmaceutical form:solution Route of administration: subcutaneous
DRUG
Pharmaceutical form:tablet Route of administration: oral
DRUG
Pharmaceutical form:solution Route of administration: subcutaneous
Timeline
First posted
Jul 25, 2014
Study start
Aug 2014
Primary completion
Nov 2015
Study completion
Nov 2015
Results posted
Not reported
Registry updated
Oct 5, 2016
Outcomes
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Time frame · Day 29 after first intake of investigational product
Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
Time frame · Day 29 after first intake of investigational product
Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
Time frame · Day 29 after first intake of investigational product
Change from baseline in glucagon levels at Day 29 after a standardized breakfast
Time frame · Day 29 after first intake of investigational product
Change in gastric emptying half life (13C-acetic acid breath test)
Time frame · Day 29 after first intake of investigational product
Proportion of patients with adverse events
Time frame · Up to Day 33 from the first intake of investigational medicinal product
Eligibility
Inclusion criteria: * Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis * Aged 20-75 years * Hemoglobin A1C ≥7.0%-≤10.0% * Fasting plasma glucose ≤180 mg/dL at screening * Stable treatment (±20%) with Lantus for 3 months or more prior to screening. * Sulfonylurea dose stable for 3 months or more prior to screening Exclusion criteria: * Type 1 diabetes mellitus * Pregnancy or lactation * Hypersensitivity to Lixisenatide * Severely uncontrolled glycemic situation * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease * History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening * History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse * Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg * Amylase and/or lipase \>3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) \>2 times the upper limit of the normal laboratory range * End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Investigational Site Number 392-107
Atsugi-shi, Japan
Investigational Site Number 392-125
Chiyoda-ku, Japan
Investigational Site Number 392-121
Chuoh-ku, Japan
Investigational Site Number 392-102
Ichihara-shi, Japan
Investigational Site Number 392-103
Kawaguchi-shi, Japan
Investigational Site Number 392-114
Kitamoto-shi, Japan
Investigational Site Number 392-122
Kobe, Japan
Investigational Site Number 392-126
Kumamoto, Japan
Investigational Site Number 392-127
Kumamoto, Japan
Investigational Site Number 392-101
Kyoto, Japan
Investigational Site Number 392-106
Matsudo-shi, Japan
Investigational Site Number 392-124
Mitaka-shi, Japan
Investigational Site Number 392-108
Mito, Japan
Investigational Site Number 392-119
Nerima-ku, Japan
Investigational Site Number 392-117
Okayama, Japan
Investigational Site Number 392-111
Sagamihara-shi, Japan
Investigational Site Number 392-110
Sapporo, Japan
Investigational Site Number 392-116
Satsumasendai-shi, Japan
Investigational Site Number 392-105
Shizuoka, Japan
Investigational Site Number 392-118
Suita-shi, Japan
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