Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
Detailed description
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.
Interventions
DRUGInsulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGPlacebo
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
: * Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history. * Patients aged 20 to 75 years at screening. * Body mass index ≤35 kg/m\^2 at screening. * Glycohemoglobin ≥7.0% and ≤10.0% at screening. * Fasting C-peptide ≥0.6 ng/mL at screening.
Exclusion criteria
* Diabetes other than T2DM. * History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening. * History of hypoglycemia unawareness. * Hemoglobinopathy or hemolytic anemia. * History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period. * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment. * Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes). * If female, pregnancy or breast-feeding. 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 |
|---|---|
| Measurement of plasma glucose concentrations | 1 day (D1) in each treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of serum C-peptide concentrations | 1 day (D1) in each treatment period |
| Measurement of plasma glucagon concentrations | 1 day (D1) in each treatment period |
| Measurement of plasma lixisenatide concentrations | 1 day (D1) in each treatment period |
| Measurement of serum insulin concentrations | 1 day (D1) in each treatment period |
| Number of patients with adverse events | Up to 2 weeks after each treatment |
| Measurement of anti-lixisenatide antibodies | 2 days (prior to first dosing and end of study visit) |
| Measurement of anti-insulin antibodies | 2 days (prior to first dosing and end of study visit) |
| Number of patients with hypoglycemic events | Up to 2 weeks after each treatment |
Countries
Japan
Outcome results
None listed