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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LIXISENATIDE AVE0010; Drug: Sitagliptin; Drug: Insulin glargine HOE901

Study type: Interventional

Funder types: Industry

Identifiers

NCT02200991

U1111-1159-5323

LIXISL06651

Details and patient eligibility

About

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 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).

Enrollment: 136 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Lixisenatide

Experimental group

Description:

Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Treatment:

Drug: Insulin glargine HOE901

Drug: LIXISENATIDE AVE0010

Sitagliptin - Januvia

Active Comparator group

Description:

50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Treatment:

Drug: Insulin glargine HOE901

Drug: Sitagliptin