Current partner codePEPTIDESDE
NCT02200991·Phase 4·INTERVENTIONAL

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Status

Completed

Phase

Phase 4

Enrollment

136

Locations

20

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full detailed description

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

Treatment arms and agents.

DRUG

LIXISENATIDE AVE0010

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

Sitagliptin

Pharmaceutical form:tablet Route of administration: oral

DRUG

Insulin glargine HOE901

Pharmaceutical form:solution Route of administration: subcutaneous

Timeline

From registration to results.

  1. First posted

    Jul 25, 2014

  2. Study start

    Aug 2014

  3. Primary completion

    Nov 2015

  4. Study completion

    Nov 2015

  5. Results posted

    Not reported

  6. Registry updated

    Oct 5, 2016

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
20 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

20 registered sites.

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

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.