Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.
Detailed description
Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGLixisenatide (AVE0010)
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor. * Signed written informed consent.
Exclusion criteria
* At the screening visit: age \<20 years. * At the screening visit: HbA1c \<7.5% or \>10%. * At the screening visit: fasting plasma glucose (FPG) \>250 mg/dL (13.8 mmol/L). * Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. * Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit. * Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician). * Laboratory findings at the screening visit, including: * Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN), * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN, * Calcitonin ≥20 pg/mL (5.9 pmol/L), * Positive serum pregnancy test. * Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol. * Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients. * Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 or end-stage renal disease for patient not treated with metformin. * Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes). * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. 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 HbA1c | Baseline, 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | Baseline, 26 weeks |
| Change in from baseline in 7 point self-monitored plasma profiles | Baseline, 26 weeks |
| Percentage of patients reaching HbA1c <7% with no body weight gain | 26 weeks |
| Change from baseline in body weight | Baseline, 26 weeks |
| Percentage of patients requiring a rescue therapy | 26 weeks |
| Percentage of patients reaching HbA1c <7% or ≤6.5% | 26 weeks |
| Number of hypoglycemic events | 26 weeks, 52 weeks |
| Number of adverse events | 26 weeks, 52 weeks |
| Measurement of anti-lixisenatide antibodies from baseline | Baseline, 26 weeks, 52 weeks |
| Measurement of anti-insulin antibodies from baseline | Baseline, 26 weeks, 52 weeks |
| Change in daily dose of insulin glargine for the combination group | Day 1, 26 weeks |
Countries
Japan
Outcome results
None listed