Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Lixisenatide (AVE0010); Device: Self-injector pen device (OptiClik®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01517412

U1111-1118-0841 (Other Identifier)

EFC12261

2011-002416-85 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

• To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

• To assess the effect of the 2 lixisenatide regimens on:

  • The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
  • Fasting Plasma Glucose (FPG)
  • 7-point Self-Monitored Plasma Glucose (SMPG) profiles
  • Body weight

• To assess the safety and tolerability of the 2 lixisenatide regimens

Full description

The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Enrollment: 451 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
• Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria

• Screening HbA1c < 7.0% and > 10.0%
• Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
• Participants who usually did not eat breakfast
• Type 1 diabetes mellitus
• Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
• Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
• Alanine aminotransferase (ALT) > 3 ULN at screening
• Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
• Any contra-indication related to metformin
• Any previous treatment with lixisenatide

The above information was not intended to contain all considerations relevant to a participant'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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451 participants in 2 patient groups

Lixisenatide Main Meal

Experimental group

Description:

Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Treatment:

Drug: Lixisenatide (AVE0010)

Device: Self-injector pen device (OptiClik®)

Drug: Metformin

Lixisenatide Breakfast

Active Comparator group

Description:

Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Treatment:

Drug: Lixisenatide (AVE0010)

Device: Self-injector pen device (OptiClik®)

Drug: Metformin