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

Diabetes Mellitus, Type 2 Clinical Trial

— LixiRam  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941367
• Other study ID #: LPS14410
• Secondary ID: U1111-1172-3026
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2017
• Est. completion date: August 4, 2017

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 4, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Lixisenatide (AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Sulfonylurea
Pharmaceutical form: tablet Route of administration: oral
• metformin
Pharmaceutical form: tablet Route of administration: oral
• basal insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
India	Investigational Site Number 356005	Ahmedabad
India	Investigational Site Number 356002	Bangalore
India	Investigational Site Number 356008	Bangalore
India	Investigational Site Number 356015	Bangalore
India	Investigational Site Number 356003	Hyderabad
India	Investigational Site Number 356009	Hyderabad
India	Investigational Site Number 356010	Hyderabad
India	Investigational Site Number 356018	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
Israel	Investigational Site Number 376001	Haifa
Israel	Investigational Site Number 376002	Safed
Kuwait	Investigational Site Number 414001	Kuwait
Turkey	Investigational Site Number 792002	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

India,  Israel,  Kuwait,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean change in HbA1c		Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Secondary	Mean change in body weight		Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Secondary	Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)		Last 14 days of Ramadan month
Secondary	Percentage of patients with HbA1C <7%		At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Secondary	Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)		At pre-Ramadan visit
Secondary	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