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Study · Randomized controlled trial · n = 184 · 2019

2 results

Safety of lixisenatide versus sulfonylurea added to basal insulin treatment in people with type 2 diabetes mellitus who elect to fast during Ramadan (LixiRam): An international, randomized, open-label trial.

Hassanein MM, Sahay R, Hafidh K, Djaballah K, Li H, Azar S, Shehadeh N, Hanif W

Diabetes research and clinical practice14 Feb 2019Cited by 20 (Europe PMC)

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

    During Ramadan fasting, documented symptomatic hypoglycemia was numerically lower with lixisenatide (3.3%, 3/91) than with sulfonylurea (8.9%, 8/90), each with basal insulin.

    In plain wordsDuring Ramadan fasting, symptomatic low blood sugar was numerically lower with lixisenatide (3.3%) than with sulfonylurea (8.9%), each with basal insulin.

    Outcome
    DecreaseDocumented symptomatic hypoglycemia during Ramadan
    Study

    n = 181

    Comparator
    Sulfonylurea with basal insulin
    Analysis
    Primary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated

    Measurements

    Participants with event
    3.3%
    lixisenatide
    Events
    3 participants
    lixisenatide, 91 assessed
    Participants with event
    8.9%
    sulfonylurea
    Events
    8 participants
    sulfonylurea, 90 assessed
    Odds ratio
    0.34 ratio
    95% CI 0.09, 1.35
    Proportion difference
    −0.06 proportion
    95% CI -0.13, 0.01

    Source sentences

    Summary
    A numerically lower percentage of participants with lixisenatide + BI (3.3%, 3/91) versus SU + BI (8.9%, 8/90) had ≥1 documented symptomatic hypoglycemia event (intent-to-treat visit 4) during Ramadan fasting (OR: 0.34; 95% CI 0.09, 1.35; proportion difference -0.06, 95% CI -0.13, 0.01)
    2 context sentences
    Summary · context
    Adding lixisenatide to basal insulin (BI) instead of sulfonylurea (SU), versus continuing SU + BI was assessed in people with type 2 diabetes mellitus (T2DM) who intended to fast during Ramadan 2017.
    Summary · context
    LixiRam (NCT02941367) was a phase 4, randomized, open-label, 12-22-week study in people with T2DM insufficiently controlled with SU + BI ± 1 oral anti-diabetic.
  2. 02HumanRandomized controlled trialSafety outcome

    During Ramadan fasting, any hypoglycemia occurred in 4.3% with lixisenatide versus 17.4% with sulfonylurea, each with basal insulin.

    In plain wordsDuring Ramadan fasting, any hypoglycemia occurred in 4.3% with lixisenatide versus 17.4% with sulfonylurea, each with basal insulin.

    Outcome
    DecreaseAny hypoglycemia during Ramadan
    Study

    n = 184

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

    Measurements

    Participants with event
    4.3%
    lixisenatide
    Events
    4 participants
    lixisenatide, 92 assessed
    Participants with event
    17.4%
    sulfonylurea
    Events
    16 participants
    sulfonylurea, 92 assessed
    Odds ratio
    0.22 ratio
    95% CI 0.07, 0.68
    Proportion difference
    −0.13 proportion
    95% CI -0.22, -0.04

    Source sentences

    Summary
    the difference was statistically significant for the 'any hypoglycemia' category (lixisenatide + BI: 4.3%, 4/92; SU + BI: 17.4%, 16/92; OR: 0.22; 95% CI 0.07, 0.68; proportion difference -0.13, 95% CI -0.22, -0.04; intent-to-treat).
    2 context sentences
    Summary · context
    Adding lixisenatide to basal insulin (BI) instead of sulfonylurea (SU), versus continuing SU + BI was assessed in people with type 2 diabetes mellitus (T2DM) who intended to fast during Ramadan 2017.
    Summary · context
    LixiRam (NCT02941367) was a phase 4, randomized, open-label, 12-22-week study in people with T2DM insufficiently controlled with SU + BI ± 1 oral anti-diabetic.

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

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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