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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200991
• Other study ID #: LIXISL06651
• Secondary ID: U1111-1159-5323
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2014
• Last updated: October 4, 2016
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous
• Sitagliptin
Pharmaceutical form:tablet Route of administration: oral
• Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Japan	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-shi
Japan	Investigational Site Number 392-126	Kumamoto-shi
Japan	Investigational Site Number 392-127	Kumamoto-shi
Japan	Investigational Site Number 392-101	Kyoto-shi
Japan	Investigational Site Number 392-106	Matsudo-shi
Japan	Investigational Site Number 392-124	Mitaka-shi
Japan	Investigational Site Number 392-108	Mito-shi
Japan	Investigational Site Number 392-119	Nerima-ku
Japan	Investigational Site Number 392-117	Okayama-shi
Japan	Investigational Site Number 392-111	Sagamihara-shi
Japan	Investigational Site Number 392-110	Sapporo-shi
Japan	Investigational Site Number 392-116	Satsumasendai-shi
Japan	Investigational Site Number 392-105	Shizuoka-shi
Japan	Investigational Site Number 392-118	Suita-shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast		Day 29 after first intake of investigational product	No
Secondary	Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast		Day 29 after first intake of investigational product	No
Secondary	Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast		Day 29 after first intake of investigational product	No
Secondary	Change from baseline in glucagon levels at Day 29 after a standardized breakfast		Day 29 after first intake of investigational product	No
Secondary	Change in gastric emptying half life (13C-acetic acid breath test)		Day 29 after first intake of investigational product	No
Secondary	Proportion of patients with adverse events		Up to Day 33 from the first intake of investigational medicinal product	Yes