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 mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
Detailed description
The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGInsulin glargine U100 (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGMetformin
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 (V1). * Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. * The total daily basal insulin dose should be stable (± 20%) and \<15 U/day for at least 1 month before the screening visit. * Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of: * Metformin; * Sulfonylurea (SU); * Glinide; * Dipeptidyl-peptidase-4 (DPP-4) inhibitor; * Sodium glucose co-transporter 2 (SGLT2) inhibitor; * Alpha glucosidase inhibitor (alpha-GI). * Signed written informed consent.
Exclusion criteria
* Age \<20 years at screening visit. * HbA1c at screening visit \<7.5% or \>9.5%. * Fasting plasma glucose (FPG) \>180 mg/dL (10.0 mmol/L) at screening visit. * 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 in the 3 months before screening visit. * Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin. Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator. * Use of thiazolidinedione (TZD) within 6 months prior to screening visit. * History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy. * Laboratory findings at the screening visit; including: * 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. * Any contraindication to metformin use according to local labeling. * History of hypersensitivity to any GLP-1 receptor agonist or to metacresol. * Contraindication to use of insulin glargine or lixisenatide according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients. * 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 now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. *
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 plasma glucose (PPG) during standardized meal test | Baseline, 26 weeks |
| Change from baseline in blood glucose excursion during standardized meal test | Baseline, 26 weeks |
| Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value) | Baseline, 26 weeks |
| Change from baseline in body weight | Baseline, 26 weeks |
| Change from baseline in FPG | Baseline, 26 weeks |
| Change from baseline in daily dose of insulin glargine | Baseline, 26 weeks |
| Percentage of patients reaching HbA1c <7% with no body weight gain | 26 weeks |
| Percentage of patients reaching HbA1c <7% or ≤6.5% | 26 weeks |
| Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia | 26 weeks |
| Percentage of patients requiring a rescue therapy | 26 weeks |
| Number of hypoglycemic events | 26 weeks |
| Number of adverse 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 reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia | 26 weeks |
Countries
Japan
Outcome results
None listed