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Study · Randomized controlled trial · n = 154 · 2022

7 results

Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes.

Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Pérez M, Bismuth E, Dib S, Cho JI, Cox D

The New England journal of medicine4 Jun 2022Cited by 120 (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: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In youths with diabetes, dulaglutide 0.75 mg reduced HbA1c more than placebo at 26 weeks.

    In plain wordsIn youths with diabetes, the lower dulaglutide dose lowered blood sugar more than placebo.

    Outcome
    DecreaseHbA1c change, lower dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.6 percentage points
    0.75-mg group
    HbA1c change
    0.6 percentage points
    placebo

    Source sentences

    Summary
    At 26 weeks, the mean glycated hemoglobin level had increased in the placebo group (0.6 percentage points) and had decreased in the dulaglutide groups (-0.6 percentage points in the 0.75-mg group and -0.9 percentage points in the 1.5-mg group, P<0.001 for both comparisons vs. placebo).
    3 context sentences
    Summary · context
    The primary end point was the change from baseline in the glycated hemoglobin level at 26 weeks.
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  2. 02HumanRandomized controlled trialEfficacy outcome

    In youths with diabetes, dulaglutide 1.5 mg reduced HbA1c more than placebo at 26 weeks.

    In plain wordsIn youths with diabetes, the higher dulaglutide dose lowered blood sugar more than placebo.

    Outcome
    DecreaseHbA1c change, higher dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −0.9 percentage points
    1.5-mg group
    HbA1c change
    0.6 percentage points
    placebo

    Source sentences

    Summary
    At 26 weeks, the mean glycated hemoglobin level had increased in the placebo group (0.6 percentage points) and had decreased in the dulaglutide groups (-0.6 percentage points in the 0.75-mg group and -0.9 percentage points in the 1.5-mg group, P<0.001 for both comparisons vs. placebo).
    3 context sentences
    Summary · context
    The primary end point was the change from baseline in the glycated hemoglobin level at 26 weeks.
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  3. 03HumanRandomized controlled trialEfficacy outcome

    In youths with diabetes, pooled dulaglutide doses increased HbA1c target achievement versus placebo.

    In plain wordsMore youths reached the blood sugar target with dulaglutide than with placebo.

    Outcome
    IncreaseHbA1c below 7.0%
    Study

    n = 154

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg or 1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    HbA1c <7.0%
    51%
    pooled dulaglutide
    HbA1c <7.0%
    14%
    placebo

    Source sentences

    Summary
    At 26 weeks, a higher percentage of participants in the pooled dulaglutide groups than in the placebo group had a glycated hemoglobin level of less than 7.0% (51% vs. 14%, P<0.001).
    3 context sentences
    Summary · context
    Secondary end points included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI.
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  4. 04HumanRandomized controlled trialEfficacy outcome

    In youths with diabetes, pooled dulaglutide doses decreased fasting glucose versus an increase with placebo.

    In plain wordsDulaglutide lowered fasting blood sugar in youths, while placebo increased it.

    Outcome
    DecreaseFasting glucose
    Study

    n = 154

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg or 1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Fasting glucose change
    −18.9 mg per deciliter
    pooled dulaglutide
    Fasting glucose change
    17.1 mg per deciliter
    placebo

    Source sentences

    Summary
    The fasting glucose concentration increased in the placebo group (17.1 mg per deciliter) and decreased in the pooled dulaglutide groups (-18.9 mg per deciliter, P<0.001), and there were no between-group differences in the change in BMI.
    3 context sentences
    Summary · context
    Secondary end points included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI.
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  5. 05HumanRandomized controlled trialEfficacy outcome

    In youths with diabetes, BMI change did not differ between dulaglutide and placebo groups.

    In plain wordsBMI changes did not differ between dulaglutide and placebo in youths with diabetes.

    Outcome
    No significant changeBMI change
    Study

    n = 154

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.75 mg or 1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The fasting glucose concentration increased in the placebo group (17.1 mg per deciliter) and decreased in the pooled dulaglutide groups (-18.9 mg per deciliter, P<0.001), and there were no between-group differences in the change in BMI.
    3 context sentences
    Summary · context
    Secondary end points included a glycated hemoglobin level of less than 7.0% and changes from baseline in the fasting glucose concentration and BMI.
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  6. 06HumanRandomized controlled trialSafety outcome

    In youths with diabetes, gastrointestinal adverse events were more frequent with dulaglutide than placebo.

    In plain wordsYouths had more digestive side effects with dulaglutide than placebo.

    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 154

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg or 1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The incidence of gastrointestinal adverse events was higher with dulaglutide therapy than with placebo.
    2 context sentences
    Summary · context
    in a 1:1:1 ratio to receive once-weekly subcutaneous injections of placebo, dulaglutide at a dose of 0.75 mg, or dulaglutide at a dose of 1.5 mg.
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,
  7. 07HumanRandomized controlled trialSafety outcome

    In youths with diabetes, dulaglutide's safety profile was consistent with reports in adults.

    In plain wordsDulaglutide's safety profile in youths was consistent with reports in adults.

    Outcome
    Not applicableSafety profile consistency
    Study

    n = 154

    Comparator
    Reported adult safety profile
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.75 mg or 1.5 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The safety profile of dulaglutide was consistent with that reported in adults.
    1 context sentence
    Summary · context
    In a double-blind, placebo-controlled, 26-week trial, we randomly assigned participants (10 to 85th percentile) being treated with lifestyle modifications alone or with metformin, with or without basal insulin,

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02963766

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Eli Lilly and Companyn = 15429 Dec 2016 to 12 Jan 2022

Type 2 Diabetes

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

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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