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Study · Randomized controlled trial · n = 150 · 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 R, Hafidh K, Djaballah K, Coudert M, Azar S, Shehadeh N, Hanif W, Hassanein M

Diabetes research and clinical practice14 Apr 2020Cited by 6 (Europe PMC)

PMID32302665 (opens in a new tab)DOI10.1016/j.diabres.2020.108148 (opens in a new tab)PepBankPUB-32302665
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Indian adults with type 2 diabetes fasting during Ramadan, symptomatic hypoglycemia affected 1.3% with lixisenatide versus 6.8% with sulphonylurea, both with insulin.

    In plain wordsIn Indian adults fasting during Ramadan, symptomatic low blood sugar was numerically less frequent with lixisenatide than sulphonylurea, both with insulin.

    Peptide
    Lixisenatide
    Outcome
    DecreaseDocumented symptomatic hypoglycemia during Ramadan
    Study

    n = 150

    Comparator
    Sulphonylurea plus basal insulin
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Participants with documented symptomatic hypoglycemia
    1
    lixisenatide plus basal insulin
    Participants with documented symptomatic hypoglycemia
    5
    sulphonylurea plus basal insulin
    Participants with documented symptomatic hypoglycemia
    1.3%
    lixisenatide plus basal insulin
    Participants with documented symptomatic hypoglycemia
    6.8%
    sulphonylurea plus basal insulin
    Odds ratio
    0.22
    between groups
    95% CI
    0.02 to 1.93
    odds ratio

    Source sentences

    Summary
    One participant (1.3%) with lixisenatide + BI vs. 5 participants (6.8%) with sulphonylurea + BI experienced ≥1 documented symptomatic hypoglycemic event during the Ramadan fast (odds ratio [OR]: 0.22; 95% confidence interval [CI]: 0.02-1.93).
    1 context sentence
    Summary · context
    Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment.
  2. 02HumanRandomized controlled trialSafety outcome

    In Indian adults with type 2 diabetes fasting during Ramadan, any hypoglycemia was numerically lower with lixisenatide (1.3%, 1/75) than with sulphonylurea (14.7%, 11/75), both with basal insulin.

    In plain wordsIn Indian adults fasting during Ramadan, low blood sugar was numerically less frequent with lixisenatide than sulphonylurea, both with insulin.

    Peptide
    Lixisenatide
    Outcome
    DecreaseAny hypoglycemia during Ramadan
    Study

    n = 150

    Comparator
    Sulphonylurea plus basal insulin
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Participants with any hypoglycemia
    1
    lixisenatide plus basal insulin, of 75
    Participants with any hypoglycemia
    11
    sulphonylurea plus basal insulin, of 75
    Any hypoglycemia incidence
    1.3%
    lixisenatide plus basal insulin
    Any hypoglycemia incidence
    14.7%
    sulphonylurea plus basal insulin
    Odds ratio
    0.09
    between groups
    95% CI
    0.01 to 0.69
    odds ratio

    Source sentences

    Summary
    Incidence of any hypoglycemia was numerically lower with lixisenatide + BI vs. sulphonylurea + BI during Ramadan fasting (1.3% [1/75] vs. 14.7% [11/75], respectively; OR: 0.09; 95% CI: 0.01-0.69).
    1 context sentence
    Summary · context
    Adults with type 2 diabetes insufficiently controlled with sulphonylurea + BI ± another oral anti-hyperglycemic drug were randomized 1:1 to receive lixisenatide + BI or to continue sulphonylurea + BI treatment.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT02941367

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

Sanofin = 18423 Feb 2017 to 4 Aug 2017

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 25 Apr 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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