A Phase 4 interventional study of Lixisenatide (AVE0010) and Sulfonylurea in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 16 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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:
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 184 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Drug: Lixisenatide (AVE0010) · Drug: metformin · Drug: basal insulin
Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment.
Drug: Sulfonylurea · Drug: metformin · Drug: basal insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Also known as: Lyxumia
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: solution for injection Route of administration: subcutaneous
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
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi