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 (LixiRam)

April 21, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380007
        • Investigational Site Number 356005
      • Bangalore, India, 560043
        • Investigational Site Number 356002
      • Bangalore, India, 560055
        • Investigational Site Number 356015
      • Bangalore, India, 560060
        • Investigational Site Number 356008
      • Hyderabad, India, 500001
        • Investigational Site Number 356009
      • Hyderabad, India, 500004
        • Investigational Site Number 356018
      • Hyderabad, India, 500072
        • Investigational Site Number 356010
      • Hyderabad, India, 500095
        • Investigational Site Number 356003
      • Jaipur, India
        • Investigational Site Number 356007
      • Madurai, India, 625020
        • Investigational Site Number 356019
      • Mumbai, India, 400007
        • Investigational Site Number 356014
      • Nagpur, India, 440010
        • Investigational Site Number 356022
  • Israel
      • Haifa, Israel, 31096
        • Investigational Site Number 376001
      • Safed, Israel, 13100
        • Investigational Site Number 376002
  • Kuwait
      • Kuwait, Kuwait
        • Investigational Site Number 414001
  • Turkey
      • Zonguldak, Turkey
        • Investigational Site Number 792002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: Lixisenatide (AVE0010)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • Lyxumia
Drug: basal insulin

Pharmaceutical form: solution for injection

Route of administration: subcutaneous
Active Comparator: 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.
Drug: Sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral

Drug: metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: basal insulin

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time Frame: Approximately 30 days (from start to end of Ramadan holy month)
Approximately 30 days (from start to end of Ramadan holy month)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in HbA1c
Time Frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Mean change in body weight
Time Frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
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)
Time Frame: Last 14 days of Ramadan month
Last 14 days of Ramadan month
Percentage of patients with HbA1C <7%
Time Frame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
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)
Time Frame: At pre-Ramadan visit
At pre-Ramadan visit
Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time Frame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
At 0-4 weeks pre- and 0-4 weeks post-Ramadan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS14410
  • U1111-1172-3026 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Sulfonylurea

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe