Type 2 Diabetes Mellitus
Conditions
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).
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
DRUGSitagliptin
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Japan
Outcome results
None listed