Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes. Secondary Objective: To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.
Detailed description
The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
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 (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (SU),Rapid-acting insulin secretagogue (Glinide),diphenyl-peptidase -4 inhibitor (DPP-4 inhibitor). * Signed written informed consent.
Exclusion criteria
* At the screening visit: Age \<20 years. * At the screening visit: HbA1c \<7.5% or \>9.5%. * At the screening visit: fasting plasma glucose (FPG) \>180 mg/dL (10.0 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 during the inclusion criteria in 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 time of screening: * Amylase and/or lipase: \>3 times the upper limit of the normal (ULN) laboratory range, * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>3 ULN, * Calcitonin ≥20 pg/mL (5.9 pmol/L), * Positive serum pregnancy test in female of childbearing potential. * Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any Glucagon-Like Peptide-1 Receptor Agonists or to metacresol. * Contraindication to use of insulin glargine according to 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/1.73 m\^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 2-hour postprandial glucose (PPG) during standardized meal test | Baseline, 26 weeks |
| Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test | Baseline, 26 weeks |
| Change from baseline in body weight | Baseline, 26 weeks |
| Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia | 26 weeks |
| Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia | 26 weeks |
| Percentage of patients reaching HbA1c <7% or ≤6.5% | 26 weeks |
| Number of adverse events | 26 weeks |
| Number of hypoglycemic events | 26 weeks |
| Measurement of anti-lixisenatide antibodies from baseline | Baseline, 26 weeks |
| Measurement of anti-insulin antibodies from baseline | Baseline, 26 weeks |
| Percentage of patients requiring a rescue therapy | 26 weeks |
Countries
Japan
Outcome results
None listed