Status:
COMPLETED
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 g...
Detailed Description
Approximately 27 weeks including a 24-week treatment period.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT01476475
Start Date
November 1 2011
End Date
December 1 2012
Last Update
February 10 2017
Active Locations (70)
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1
Investigational Site Number 840408
Little Rock, Arkansas, United States, 72205
2
Investigational Site Number 840412
Paramount, California, United States, 90723
3
Investigational Site Number 840401
Larenceville, Georgia, United States, 30045
4
Investigational Site Number 840417
Roswell, Georgia, United States, 30076