Clinical trial NCT02200991: Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Official title: A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
timeFrame: Day 29 after first intake of investigational product
Secondary outcomes:
measure: Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
timeFrame: Day 29 after first intake of investigational product
measure: Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
timeFrame: Day 29 after first intake of investigational product
measure: Change from baseline in glucagon levels at Day 29 after a standardized breakfast
timeFrame: Day 29 after first intake of investigational product
measure: Change in gastric emptying half life (13C-acetic acid breath test)
timeFrame: Day 29 after first intake of investigational product
measure: Proportion of patients with adverse events
timeFrame: Up to Day 33 from the first intake of investigational medicinal product
Other outcomes:
Locations:
city: Atsugi-shi
country: Japan
facility: Investigational Site Number 392-107
city: Chiyoda-ku
country: Japan
facility: Investigational Site Number 392-125
city: Chuoh-ku
country: Japan
facility: Investigational Site Number 392-121
city: Ichihara-shi
country: Japan
facility: Investigational Site Number 392-102
city: Kawaguchi-shi
country: Japan
facility: Investigational Site Number 392-103
city: Kitamoto-shi
country: Japan
facility: Investigational Site Number 392-114
city: Kobe-shi
country: Japan
facility: Investigational Site Number 392-122
city: Kumamoto-shi
country: Japan
facility: Investigational Site Number 392-126
city: Kumamoto-shi
country: Japan
facility: Investigational Site Number 392-127
city: Kyoto-shi
country: Japan
facility: Investigational Site Number 392-101
city: Matsudo-shi
country: Japan
facility: Investigational Site Number 392-106
city: Mitaka-shi
country: Japan
facility: Investigational Site Number 392-124
city: Mito-shi
country: Japan
facility: Investigational Site Number 392-108
city: Nerima-ku
country: Japan
facility: Investigational Site Number 392-119
city: Okayama-shi
country: Japan
facility: Investigational Site Number 392-117
city: Sagamihara-shi
country: Japan
facility: Investigational Site Number 392-111
city: Sapporo-shi
country: Japan
facility: Investigational Site Number 392-110
city: Satsumasendai-shi
country: Japan
facility: Investigational Site Number 392-116
city: Shizuoka-shi
country: Japan
facility: Investigational Site Number 392-105
city: Suita-shi
country: Japan
facility: Investigational Site Number 392-118
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.