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Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

NCT02941367

CompletedPhase 4

Sponsor: Sanofi

Conditions: Diabetes Mellitus, Type 2

Interventions: Lixisenatide (AVE0010), Sulfonylurea, metformin, basal insulin

Countries: India, Israel, Kuwait, Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (16)

Ahmedabad, India
Bangalore, India
Bangalore, India
Bangalore, India
Hyderabad, India
Hyderabad, India
Hyderabad, India
Hyderabad, India
Jaipur, India
Madurai, India
Mumbai, India
Nagpur, India
Haifa, Israel
Safed, Israel
Kuwait City, Kuwait
Zonguldak, Turkey (Türkiye)