DRUG
Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010
Pharmaceutical form: solution Route of administration: subcutaneous
Status
Completed
Phase
Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
1
Study 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.
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
DRUG
Pharmaceutical form: solution Route of administration: subcutaneous
DRUG
Pharmaceutical form: solution Route of administration: subcutaneous
DRUG
Pharmaceutical form: solution Route of administration: subcutaneous
Timeline
First posted
Mar 18, 2016
Study start
Apr 2016
Primary completion
Jun 2016
Study completion
Jun 2016
Results posted
Not reported
Registry updated
Jun 16, 2020
Outcomes
Measurement of plasma glucose concentrations
Time frame · 1 day (D1) in each treatment period
Measurement of serum insulin concentrations
Time frame · 1 day (D1) in each treatment period
Measurement of serum C-peptide concentrations
Time frame · 1 day (D1) in each treatment period
Measurement of plasma glucagon concentrations
Time frame · 1 day (D1) in each treatment period
Measurement of plasma lixisenatide concentrations
Time frame · 1 day (D1) in each treatment period
Number of patients with hypoglycemic events
Time frame · Up to 2 weeks after each treatment
Number of patients with adverse events
Time frame · Up to 2 weeks after each treatment
Measurement of anti-lixisenatide antibodies
Time frame · 2 days (prior to first dosing and end of study visit)
Measurement of anti-insulin antibodies
Time frame · 2 days (prior to first dosing and end of study visit)
Eligibility
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.
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Investigational Site Number 392001
Fukuoka, Japan
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