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Study · Randomized controlled trial · 2019

12 results

Efficacy and safety of an expanded dulaglutide dose range: A phase 2, placebo-controlled trial in patients with type 2 diabetes using metformin.

Frias JP, Wynne AG, Matyjaszek-Matuszek B, Bartaskova D, Cox DA, Woodward B, Li YG, Tham LS, Milicevic Z

Diabetes, obesity & metabolism3 Jun 2019Cited by 37 (Europe PMC)

PMID31050143 (opens in a new tab)DOI10.1111/dom.13764 (opens in a new tab)PepBankPUB-31050143
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 1.5 mg reduced HbA1c more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 1.5 mg reduced HbA1c more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    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 · 18 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.23%
    dulaglutide 1.5 mg
    HbA1c change
    −0.44%
    placebo

    Source sentences

    Summary
    HbA1c reduction at 18 weeks was significantly greater with dulaglutide vs placebo (placebo, -0.44% ± 0.10% [-4.8 ± 1.1 mmol/mol]; dulaglutide 1.5 mg, -1.23% ± 0.10% [-13.5 ± 1.1 mmol/mol]
    2 context sentences
    Summary · context
    [-15.3 ± 1.1 mmol/mol]; P < 0.001, each dose)
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 3.0 mg reduced HbA1c more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 3.0 mg reduced HbA1c more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3.0 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.31%
    dulaglutide 3.0 mg
    HbA1c change
    −0.44%
    placebo

    Source sentences

    Summary
    HbA1c reduction at 18 weeks was significantly greater with dulaglutide vs placebo (placebo, -0.44% ± 0.10% [-4.8 ± 1.1 mmol/mol]; dulaglutide 1.5 mg, -1.23% ± 0.10% [-13.5 ± 1.1 mmol/mol]; dulaglutide 3.0 mg, -1.31% ± 0.10% [-14.3 ± 1.1 mmol/mol]; dulaglutide 4.5 mg, -1.40% ± 0.10% [-15.3 ± 1.1 mmol…
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 4.5 mg reduced HbA1c more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 4.5 mg reduced HbA1c more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.4%
    dulaglutide 4.5 mg
    HbA1c change
    −0.44%
    placebo

    Source sentences

    Summary
    HbA1c reduction at 18 weeks was significantly greater with dulaglutide vs placebo (placebo, -0.44% ± 0.10% [-4.8 ± 1.1 mmol/mol]; dulaglutide 1.5 mg, -1.23% ± 0.10% [-13.5 ± 1.1 mmol/mol]; dulaglutide 3.0 mg, -1.31% ± 0.10% [-14.3 ± 1.1 mmol/mol]; dulaglutide 4.5 mg, -1.40% ± 0.10% [-15.3 ± 1.1 mmol…
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 1.5 mg reduced body weight more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 1.5 mg reduced weight more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.5 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    Weight change
    −2.8 kg
    dulaglutide 1.5 mg
    Weight change
    −1.6 kg
    placebo

    Source sentences

    Summary
    as were changes in body weight (placebo, -1.6 ± 0.39 kg; dulaglutide 1.5 mg, -2.8 ± 0.39 kg; dulaglutide 3.0 mg, -3.9 ± 0.39 kg; dulaglutide 4.5 mg, -4.1 ± 0.41 kg; P < 0.001, each dose).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 3.0 mg reduced body weight more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 3.0 mg reduced weight more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    Weight change
    −3.9 kg
    dulaglutide 3.0 mg
    Weight change
    −1.6 kg
    placebo

    Source sentences

    Summary
    as were changes in body weight (placebo, -1.6 ± 0.39 kg; dulaglutide 1.5 mg, -2.8 ± 0.39 kg; dulaglutide 3.0 mg, -3.9 ± 0.39 kg; dulaglutide 4.5 mg, -4.1 ± 0.41 kg; P < 0.001, each dose).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 4.5 mg reduced body weight more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 4.5 mg reduced weight more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4.5 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    Weight change
    −4.1 kg
    dulaglutide 4.5 mg
    Weight change
    −1.6 kg
    placebo

    Source sentences

    Summary
    as were changes in body weight (placebo, -1.6 ± 0.39 kg; dulaglutide 1.5 mg, -2.8 ± 0.39 kg; dulaglutide 3.0 mg, -3.9 ± 0.39 kg; dulaglutide 4.5 mg, -4.1 ± 0.41 kg; P < 0.001, each dose).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 1.5 mg reduced fasting serum glucose more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 1.5 mg reduced fasting glucose more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseFasting serum glucose change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    FSG change
    −36.2 mg/dL
    dulaglutide 1.5 mg
    FSG change
    −12.4 mg/dL
    placebo

    Source sentences

    Summary
    All three dulaglutide doses significantly reduced FSG from baseline (1.5 mg, -36.2 ± 4.7 mg/dL [-2.0 ± 0.3 mmol/L]; 3.0 mg, -34.5 ± 4.5 mg/dL [-1.9 ± 0.3 mmol/L]; 4.5 mg, -38.0 ± 4.7 mg/dL [-2.1 ± 0.3 mmol/L]) vs placebo (-12.4 ± 4.5 mg/dL [-0.7 ± 0.3 mmol/L]) (P < 0.001, all).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 3.0 mg reduced fasting serum glucose more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 3.0 mg reduced fasting glucose more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseFasting serum glucose change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3.0 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    FSG change
    −34.5 mg/dL
    dulaglutide 3.0 mg
    FSG change
    −12.4 mg/dL
    placebo

    Source sentences

    Summary
    All three dulaglutide doses significantly reduced FSG from baseline (1.5 mg, -36.2 ± 4.7 mg/dL [-2.0 ± 0.3 mmol/L]; 3.0 mg, -34.5 ± 4.5 mg/dL [-1.9 ± 0.3 mmol/L]; 4.5 mg, -38.0 ± 4.7 mg/dL [-2.1 ± 0.3 mmol/L]) vs placebo (-12.4 ± 4.5 mg/dL [-0.7 ± 0.3 mmol/L]) (P < 0.001, all).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  9. 09HumanRandomized controlled trialEfficacy outcome

    In T2D patients using metformin, dulaglutide 4.5 mg reduced fasting serum glucose more than placebo.

    In plain wordsIn T2D patients using metformin, dulaglutide 4.5 mg reduced fasting glucose more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseFasting serum glucose change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    4.5 mg once weekly · subcutaneous · 18 weeksAs given in this study (human).

    Measurements

    FSG change
    −38 mg/dL
    dulaglutide 4.5 mg
    FSG change
    −12.4 mg/dL
    placebo

    Source sentences

    Summary
    All three dulaglutide doses significantly reduced FSG from baseline (1.5 mg, -36.2 ± 4.7 mg/dL [-2.0 ± 0.3 mmol/L]; 3.0 mg, -34.5 ± 4.5 mg/dL [-1.9 ± 0.3 mmol/L]; 4.5 mg, -38.0 ± 4.7 mg/dL [-2.1 ± 0.3 mmol/L]) vs placebo (-12.4 ± 4.5 mg/dL [-0.7 ± 0.3 mmol/L]) (P < 0.001, all).
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  10. 10HumanRandomized controlled trialSafety outcome

    In T2D patients using metformin, higher dulaglutide doses had safety profiles consistent with the established dulaglutide profile.

    In plain wordsIn T2D patients using metformin, higher dulaglutide doses had safety profiles consistent with the established profile.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableHigher-dose safety profile
    Study

    n: not reported in source

    Comparator
    Established dulaglutide safety profile
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 18 weeksAs given in this study (human).

    Source sentences

    Summary
    Safety profiles of the higher doses were consistent with the established safety profile for dulaglutide.
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  11. 11HumanRandomized controlled trialSafety outcome

    In T2D patients using metformin, gastrointestinal events with dulaglutide were mostly mild to moderate.

    In plain wordsIn T2D patients using metformin, stomach and bowel events with dulaglutide were mostly mild to moderate.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableGastrointestinal event severity
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 18 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal events were mostly mild to moderate, and was dose-related for nausea.
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).
  12. 12HumanRandomized controlled trialSafety outcome

    In T2D patients using metformin, nausea with dulaglutide was dose-related.

    In plain wordsIn T2D patients using metformin, nausea with dulaglutide varied with dose.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableDose-related nausea
    Study

    n: not reported in source

    Comparator
    Other dulaglutide doses
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 18 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal events were mostly mild to moderate, and was dose-related for nausea.
    1 context sentence
    Summary · context
    This 18-week, double-blind, phase 2 trial randomized 318 patients with T2D using ≥1500 mg metformin, to receive subcutaneous injection of placebo (n = 82), dulaglutide 1.5 mg (n = 81), dulaglutide 3.0 mg (n = 79) or dulaglutide 4.5 mg (n = 76).

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

    22 Oct 2026, 02:26 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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