Diabetes Mellitus, Type 2
Conditions
Brief 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.
Detailed description
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
DRUGLixisenatide (AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUGSulfonylurea
Pharmaceutical form: tablet Route of administration: oral
DRUGmetformin
Pharmaceutical form: tablet Route of administration: oral
DRUGbasal insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L) | Approximately 30 days (from start to end of Ramadan holy month) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L) | 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) | At 0-4 weeks pre- and 0-4 weeks post-Ramadan |
| Percentage of patients with HbA1C <7% | At 0-4 weeks pre- and 0-4 weeks post-Ramadan |
| Mean change in body weight | 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) | Last 14 days of Ramadan month |
| Mean change in HbA1c | Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan |
Countries
India, Israel, Kuwait, Turkey (Türkiye)
Outcome results
None listed