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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: LIXISENATIDE AVE0010
* Drug: Sitagliptin
* Drug: Insulin glargine HOE901


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lixisenatide<br>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. | Drug: LIXISENATIDE AVE0010<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>Drug: Insulin glargine HOE901<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>* Other names: Lantus;|
| Active Comparator: Sitagliptin - Januvia<br>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. | Drug: Sitagliptin<br>* Pharmaceutical form:tablet Route of administration: oral<br>* Other names: Januvia;Drug: Insulin glargine HOE901<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast |  | Day 29 after first intake of investigational product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast |  | Day 29 after first intake of investigational product | 
| Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast |  | Day 29 after first intake of investigational product | 
| Change from baseline in glucagon levels at Day 29 after a standardized breakfast |  | Day 29 after first intake of investigational product | 
| Change in gastric emptying half life (13C-acetic acid breath test) |  | Day 29 after first intake of investigational product | 
| Proportion of patients with adverse events |  | Up to Day 33 from the first intake of investigational medicinal product |