DRUG
Lixisenatide (AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Status
Completed
Phase
Phase 4
Enrollment
184
Locations
16
Results
Not posted
Publications
2
Study summary
Primary Objective: To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU). Secondary Objectives: * To assess effect of lixisenatide versus SU on: * Changes in glycemic control; * Changes in body weight. * To assess overall safety of lixisenatide and SU.
The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).
Interventions
DRUG
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUG
Pharmaceutical form: tablet Route of administration: oral
DRUG
Pharmaceutical form: tablet Route of administration: oral
DRUG
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Timeline
First posted
Oct 21, 2016
Study start
Feb 23, 2017
Primary completion
Aug 4, 2017
Study completion
Aug 4, 2017
Results posted
Not reported
Registry updated
Apr 25, 2022
Outcomes
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time frame · Approximately 30 days (from start to end of Ramadan holy month)
Mean change in HbA1c
Time frame · Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Mean change in body weight
Time frame · Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)
Time frame · Last 14 days of Ramadan month
Percentage of patients with HbA1C <7%
Time frame · At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)
Time frame · At pre-Ramadan visit
Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time frame · At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Eligibility
Inclusion criteria : * Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug. * Patients who express the intention to fast during Ramadan. * Signed informed consent. Exclusion criteria: * At the time of screening age \< legal age of majority. * Glycated hemoglobin (HbA1c) at screening visit: \<7.5% or \>10%. * Body mass index (BMI) \<20kg/m\^2. * Treatment with basal insulin for less than 6 months prior to screening. * Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and \<20% dose change) in the last 8 weeks prior to screening. * Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening. * Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. * Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided. * Type 1, gestational or secondary diabetes. * History of diabetic ketoacidosis. * History of hypoglycemia unawareness. * Any medical contraindication for sustained and safe fasting. * Pregnant or breast-feeding women. * Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. * Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients. * All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study locations
India · Israel · Kuwait · Turkey (Türkiye). Showing up to 24 locations stored in the fast local snapshot.
Investigational Site Number 356005
Ahmedabad, India
Investigational Site Number 356002
Bangalore, India
Investigational Site Number 356015
Bangalore, India
Investigational Site Number 356008
Bangalore, India
Investigational Site Number 356009
Hyderabad, India
Investigational Site Number 356018
Hyderabad, India
Investigational Site Number 356010
Hyderabad, India
Investigational Site Number 356003
Hyderabad, India
Investigational Site Number 356007
Jaipur, India
Investigational Site Number 356019
Madurai, India
Investigational Site Number 356014
Mumbai, India
Investigational Site Number 356022
Nagpur, India
Investigational Site Number 376001
Haifa, Israel
Investigational Site Number 376002
Safed, Israel
Investigational Site Number 414001
Kuwait City, Kuwait
Investigational Site Number 792002
Zonguldak, Turkey (Türkiye)
Publications
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