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

NCT ID: NCT02941367

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2017-08-04

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lyxumia

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.

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

basal insulin

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Sulfonylurea

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.

Group Type: ACTIVE_COMPARATOR

Sulfonylurea

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

basal insulin

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Interventions

Lixisenatide (AVE0010)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

metformin

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

basal insulin

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lyxumia

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 356005

Ahmedabad, , India

Investigational Site Number 356002

Bangalore, , India

Investigational Site Number 356015

Bangalore, , India

Investigational Site Number 356008

Bangalore, , India

Investigational Site Number 356009

Hyderabad, , India

Investigational Site Number 356018

Hyderabad, , India

Investigational Site Number 356010

Hyderabad, , India

Investigational Site Number 356003

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, , India

Investigational Site Number 376001

Haifa, , Israel

Investigational Site Number 376002

Safed, , Israel

Investigational Site Number 414001

Kuwait City, , Kuwait

Investigational Site Number 792002

Zonguldak, , Turkey (Türkiye)

Countries

India; Israel; Kuwait; Turkey (Türkiye)

References

Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

Reference Type: DERIVED

PMID: 37435938 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32302665 (View on PubMed)

Other Identifiers

U1111-1172-3026

Identifier Type: OTHER

Identifier Source: secondary_id

LPS14410

Identifier Type: -

Identifier Source: org_study_id