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Trial · Interventional

CompletedPhase 4Registry data

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

Short name LixiRam

NCTNCT02941367 (opens ClinicalTrials.gov in a new tab)Other idLPS14410Other idU1111-1172-3026
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
184 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Open label (no masking)
Countries
4 countries

India, Israel, Kuwait, Turkey (Türkiye)

Start
23 Feb 2017
Primary completion
4 Aug 2017
Completion
4 Aug 2017
First posted
21 Oct 2016 (estimated)
Last update posted
25 Apr 2022
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018
  1. Ph 4

    LixiRam

    NCT02941367

    23 Feb 2017 to 4 Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lixisenatide (AVE0010)Drug
  • SulfonylureaDrug
  • metforminDrug
  • basal insulinDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

Secondary outcomes(6)

  1. Mean change in HbA1c

    Time frame · Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

  2. Mean change in body weight

    Time frame · Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

  3. Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)

    Time frame · Last 14 days of Ramadan month

  4. Percentage of patients with HbA1C <7%

    Time frame · At 0-4 weeks pre- and 0-4 weeks post-Ramadan

  5. Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)

    Time frame · At pre-Ramadan visit

  6. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

2 results

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.

Sahay et al. 2020Diabetes research and clinical practicecited by 6

PMID 32302665DOI 10.1016/j.diabres.2020.108148PUB-32302665

Free to read · publisher termsCC BY-NC-ND2 results
Read at sourceSee results (2)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLee 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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