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 | Completed Phase 4

• 2 other identifiers: LPS14410U1111-1172-3026
• Study Type: interventional
• Target: 184
• Locations: 4 countries
• Sites: 16

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean change in HbA1c

  Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

• Mean change in body weight

  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)

  Last 14 days of Ramadan month

• Percentage of patients with HbA1C <7%

  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)

  At pre-Ramadan visit

Study Arms (2)

Lyxumia

EXPERIMENTAL

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

Sulfonylurea

ACTIVE COMPARATOR

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

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: Lyxumia

Lyxumia

Sulfonylurea DRUG

Pharmaceutical form: tablet Route of administration: oral

Sulfonylurea

metformin DRUG

Pharmaceutical form: tablet Route of administration: oral

Lyxumia; Sulfonylurea

basal insulin DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Lyxumia; Sulfonylurea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (16)

Investigational Site Number 356005

Ahmedabad, 380007, India

Location

Investigational Site Number 356002

Bangalore, 560043, India

Location

Investigational Site Number 356015

Bangalore, 560055, India

Location

Investigational Site Number 356008

Bangalore, 560060, India

Location

Investigational Site Number 356009

Hyderabad, 500001, India

Location

Investigational Site Number 356018

Hyderabad, 500004, India

Location

Investigational Site Number 356010

Hyderabad, 500072, India

Location

Investigational Site Number 356003

Hyderabad, 500095, India

Location

Investigational Site Number 356007

Jaipur, India

Location

Investigational Site Number 356019

Madurai, 625020, India

Location

Investigational Site Number 356014

Mumbai, 400007, India

Location

Investigational Site Number 356022

Nagpur, 440010, India

Location

Investigational Site Number 376001

Haifa, 31096, Israel

Location

Investigational Site Number 376002

Safed, 13100, Israel

Location

Investigational Site Number 414001

Kuwait City, Kuwait

Location

Investigational Site Number 792002

Zonguldak, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37435938 DERIVED

• 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.

  PMID: 32302665 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Sulfonylurea Compounds; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 21, 2016
• Study Start: February 23, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1); IL (2); KU (1); IN (12)