Status:
COMPLETED
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT01517412
Start Date
February 1 2012
End Date
May 1 2013
Last Update
October 14 2016
Active Locations (82)
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1
Investigational Site Number 840112
Glendale, Arizona, United States, 85306
2
Investigational Site Number 840113
Mesa, Arizona, United States, 85213
3
Investigational Site Number 840105
Phoenix, Arizona, United States, 85028
4
Investigational Site Number 840102
Tempe, Arizona, United States, 85282