Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Sanofi

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin glargine; Drug: Insulin glargine /lixisenatide Fixed Ratio Combination; Drug: Metformin (Background drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476475

2011-002090-36 (EudraCT Number)

U1111-1121-7111 (Other Identifier)

ACT12374

Details and patient eligibility

About

Primary Objective:

• The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

• To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

  • Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
  • Percentage of participants reaching HbA1c <7% or ≤6.5%;
  • 7-point Self-Monitored Plasma Glucose (SMPG) profile;
  • Body weight;
  • Insulin glargine dose
  • Fasting Plasma Glucose (FPG);
  • Percentage of participants requiring rescue therapy during the 24-week open label treatment period;

• To assess safety and tolerability of insulin glargine/lixisenatide FRC.

Full description

Approximately 27 weeks including a 24-week treatment period.

Enrollment: 323 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.
• Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.

Exclusion criteria

• Age < legal age of adulthood (18 years).
• Screening HbA1c <7% or >10%.
• Screening FPG >250 mg/dL (>13.9 mmol/L).
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
• Type 1 diabetes mellitus.
• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
• Use of insulin within the last 6 months.
• Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
• Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN) at screening.
• Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
• Alanine Transferase (ALT) >3 ULN 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).
• Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively.
• Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
• Body Mass Index (BMI) ≤20 or >40 kg/m^2.
• Any previous treatment with lixisenatide

The above information is 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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323 participants in 2 patient groups

Insulin glargine/Lixisenatide Fixed Ratio Combination (FRC)

Experimental group

Description:

FRC injected once daily (QD) for 24 weeks. Dose individually adjusted.

Treatment:

Drug: Metformin (Background drug)

Drug: Insulin glargine /lixisenatide Fixed Ratio Combination

Insulin glargine

Active Comparator group

Description:

Insulin glargine QD for 24 weeks. Dose individually adjusted.

Treatment:

Drug: Metformin (Background drug)

Drug: Insulin glargine