Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan (LIXILAN JP-O2)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Oral anti-diabetic drugs; Drug: Insulin glargine/lixisenatide (HOE901/AVE0010); Drug: Insulin glargine (HOE901)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02752828

EFC14114

U1111-1176-8450 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 521 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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521 participants in 2 patient groups

LixiLan

Experimental group

Description:

LixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

Treatment:

Drug: Insulin glargine/lixisenatide (HOE901/AVE0010)

Drug: Oral anti-diabetic drugs

insulin glargine

Active Comparator group

Description:

Insulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

Treatment:

Drug: Insulin glargine (HOE901)

Drug: Oral anti-diabetic drugs