Clinical trial NCT02941367: 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
Official title: International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
timeFrame: Approximately 30 days (from start to end of Ramadan holy month)
Secondary outcomes:
measure: Mean change in HbA1c
timeFrame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
measure: Mean change in body weight
timeFrame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
measure: Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)
timeFrame: Last 14 days of Ramadan month
measure: Percentage of patients with HbA1C <7%
timeFrame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
measure: Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)
timeFrame: At pre-Ramadan visit
measure: Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
timeFrame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Investigational Site Number 356005
city: Bangalore
country: India
facility: Investigational Site Number 356002
city: Bangalore
country: India
facility: Investigational Site Number 356015
city: Bangalore
country: India
facility: Investigational Site Number 356008
city: Hyderabad
country: India
facility: Investigational Site Number 356009
city: Hyderabad
country: India
facility: Investigational Site Number 356018
city: Hyderabad
country: India
facility: Investigational Site Number 356010
city: Hyderabad
country: India
facility: Investigational Site Number 356003
city: Jaipur
country: India
facility: Investigational Site Number 356007
city: Madurai
country: India
facility: Investigational Site Number 356019
city: Mumbai
country: India
facility: Investigational Site Number 356014
city: Nagpur
country: India
facility: Investigational Site Number 356022
city: Haifa
country: Israel
facility: Investigational Site Number 376001
city: Safed
country: Israel
facility: Investigational Site Number 376002
city: Kuwait
country: Kuwait
facility: Investigational Site Number 414001
city: Zonguldak
country: Turkey
facility: Investigational Site Number 792002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Sahay R, Hafidh K, Djaballah K, Coudert M, Azar S, Shehadeh N, Hanif W, Hassanein M. Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. Diabetes Res Clin Pract. 2020 May;163:108148. doi: 10.1016/j.diabres.2020.108148. Epub 2020 Apr 14.