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Study · Randomized controlled trial · 2022

19 results

Pharmacokinetics, Pharmacodynamics, and Safety of Dulaglutide After Single or Multiple Doses in Chinese Healthy Subjects and Patients with T2DM: A Randomized, Placebo-Controlled, Phase I Study.

Xu J, Zhang Y, Li Y, Zhao X, Zhou W, Loghin C, Tham LS, Cui X, Cui Y, Wang W

Advances in therapy17 Nov 2021Cited by 10 (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 study19

19 results from studies that gave the peptide. 19 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, single-dose dulaglutide 0.5 mg produced a geometric mean maximum concentration of 29.4 ng/mL.

    In plain wordsIn healthy Chinese subjects, dulaglutide 0.5 mg produced a peak blood concentration of 29.4 ng/mL.

    Outcome
    Not applicableSingle-dose Cmax at 0.5 mg
    Study

    n: not reported in source

    Healthy Chinese subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single doseAs given in this study (human).

    Measurements

    Cmax
    29.4 ng/mL
    healthy subjects, 0.5 mg

    Source sentences

    Summary
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, single-dose dulaglutide 0.75 mg produced a geometric mean maximum concentration of 44.2 ng/mL.

    In plain wordsIn healthy Chinese subjects, dulaglutide 0.75 mg produced a peak blood concentration of 44.2 ng/mL.

    Outcome
    Not applicableSingle-dose Cmax at 0.75 mg
    Study

    n: not reported in source

    Healthy Chinese subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg single doseAs given in this study (human).

    Measurements

    Cmax
    44.2 ng/mL
    healthy subjects, 0.75 mg

    Source sentences

    Summary
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, single-dose dulaglutide 1.5 mg produced a geometric mean maximum concentration of 81.5 ng/mL.

    In plain wordsIn healthy Chinese subjects, dulaglutide 1.5 mg produced a peak blood concentration of 81.5 ng/mL.

    Outcome
    Not applicableSingle-dose Cmax at 1.5 mg
    Study

    n: not reported in source

    Healthy Chinese subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg single doseAs given in this study (human).

    Measurements

    Cmax
    81.5 ng/mL
    healthy subjects, 1.5 mg

    Source sentences

    Summary
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, weekly dulaglutide 0.5 mg produced a geometric mean maximum concentration of 26.3 ng/mL.

    In plain wordsIn Chinese patients with diabetes, weekly dulaglutide 0.5 mg produced a peak concentration of 26.3 ng/mL.

    Outcome
    Not applicableRepeated-dose Cmax at 0.5 mg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg weekly · 4 weeksAs given in this study (human).

    Measurements

    Cmax
    26.3 ng/mL
    patients with diabetes, 0.5 mg

    Source sentences

    Summary
    Following weekly administration in patients with T2DM for 4 weeks, Cmax were 26.3, 41.4, and 70.2 ng/mL, respectively, with accumulation ratios of 1.33-1.39.
    4 context sentences
    Summary · context
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, weekly dulaglutide 0.75 mg produced a geometric mean maximum concentration of 41.4 ng/mL.

    In plain wordsIn Chinese patients with diabetes, weekly dulaglutide 0.75 mg produced a peak concentration of 41.4 ng/mL.

    Outcome
    Not applicableRepeated-dose Cmax at 0.75 mg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg weekly · 4 weeksAs given in this study (human).

    Measurements

    Cmax
    41.4 ng/mL
    patients with diabetes, 0.75 mg

    Source sentences

    Summary
    Following weekly administration in patients with T2DM for 4 weeks, Cmax were 26.3, 41.4, and 70.2 ng/mL, respectively, with accumulation ratios of 1.33-1.39.
    4 context sentences
    Summary · context
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, weekly dulaglutide 1.5 mg produced a geometric mean maximum concentration of 70.2 ng/mL.

    In plain wordsIn Chinese patients with diabetes, weekly dulaglutide 1.5 mg produced a peak concentration of 70.2 ng/mL.

    Outcome
    Not applicableRepeated-dose Cmax at 1.5 mg
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.5 mg weekly · 4 weeksAs given in this study (human).

    Measurements

    Cmax
    70.2 ng/mL
    patients with diabetes, 1.5 mg

    Source sentences

    Summary
    Following weekly administration in patients with T2DM for 4 weeks, Cmax were 26.3, 41.4, and 70.2 ng/mL, respectively, with accumulation ratios of 1.33-1.39.
    4 context sentences
    Summary · context
    Following a single-dose administration of 0.5 mg, 0.75 mg, or 1.5 mg dulaglutide in healthy subjects, geometric mean maximum concentrations (Cmax) were 29.4, 44.2, and 81.5 ng/mL, respectively.
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  7. 07HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, repeated dulaglutide dosing produced accumulation ratios of 1.33-1.39.

    In plain wordsIn Chinese patients with diabetes, dulaglutide accumulation ratios were 1.33-1.39 after repeated doses.

    Outcome
    Not applicableAccumulation ratio
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · 4 weeksAs given in this study (human).

    Measurements

    Accumulation ratio
    1.33 to 1.39 ratio
    weekly dosing for 4 weeks

    Source sentences

    Summary
    Following weekly administration in patients with T2DM for 4 weeks, Cmax were 26.3, 41.4, and 70.2 ng/mL, respectively, with accumulation ratios of 1.33-1.39.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  8. 08HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, dulaglutide had a geometric mean half-life of 4-5 days.

    In plain wordsIn healthy Chinese subjects, dulaglutide's half-life was 4-5 days.

    Outcome
    Not applicableHalf-life in healthy subjects
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Half-life
    4 to 5 days
    healthy subjects

    Source sentences

    Summary
    Geometric mean for half-life of 4-5 days and median time to Cmax (tmax) of approximately 48 h were observed in both study populations.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  9. 09HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, dulaglutide had a geometric mean half-life of 4-5 days.

    In plain wordsIn Chinese patients with diabetes, dulaglutide's half-life was 4-5 days.

    Outcome
    Not applicableHalf-life in patients with diabetes
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Half-life
    4 to 5 days
    patients with diabetes

    Source sentences

    Summary
    Geometric mean for half-life of 4-5 days and median time to Cmax (tmax) of approximately 48 h were observed in both study populations.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  10. 10HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, dulaglutide reached its median maximum concentration at approximately 48 h.

    In plain wordsIn healthy Chinese subjects, dulaglutide reached its peak concentration after about 48 hours.

    Outcome
    Not applicableTime to Cmax in healthy subjects
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Tmax
    ≈ 48 h
    healthy subjects

    Source sentences

    Summary
    Geometric mean for half-life of 4-5 days and median time to Cmax (tmax) of approximately 48 h were observed in both study populations.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  11. 11HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, dulaglutide reached its median maximum concentration at approximately 48 h.

    In plain wordsIn Chinese patients with diabetes, dulaglutide reached its peak concentration after about 48 hours.

    Outcome
    Not applicableTime to Cmax in patients with diabetes
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Tmax
    ≈ 48 h
    patients with diabetes

    Source sentences

    Summary
    Geometric mean for half-life of 4-5 days and median time to Cmax (tmax) of approximately 48 h were observed in both study populations.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  12. 12HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese subjects, dulaglutide exposure increased proportionally with dose after single dosing.

    In plain wordsIn healthy Chinese subjects, higher dulaglutide doses produced proportional increases in drug exposure.

    Outcome
    IncreaseDose proportionality after single dosing
    Study

    n: not reported in source

    Comparator
    Lower dulaglutide doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Dose-proportional increases in drug exposure were observed after both single and multiple dosing.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  13. 13HumanRandomized controlled trialPharmacokinetics

    In Chinese patients with diabetes, dulaglutide exposure increased proportionally with dose after multiple dosing.

    In plain wordsIn Chinese patients with diabetes, higher dulaglutide doses produced proportional increases in drug exposure.

    Outcome
    IncreaseDose proportionality after multiple dosing
    Study

    n: not reported in source

    Comparator
    Lower dulaglutide doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Dose-proportional increases in drug exposure were observed after both single and multiple dosing.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  14. 14HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with diabetes, dulaglutide 0.75 mg significantly reduced baseline-corrected fasting glucose.

    In plain wordsIn Chinese patients with diabetes, fasting glucose fell after dulaglutide 0.75 mg.

    Outcome
    DecreaseFasting glucose at 0.75 mg
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant reductions in baseline-corrected fasting glucose and hemoglobin A1c (HbA1c) were observed in patients with T2DM who received dulaglutide 0.75 mg and 1.5 mg.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  15. 15HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with diabetes, dulaglutide 1.5 mg significantly reduced baseline-corrected fasting glucose.

    In plain wordsIn Chinese patients with diabetes, fasting glucose fell after dulaglutide 1.5 mg.

    Outcome
    DecreaseFasting glucose at 1.5 mg
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant reductions in baseline-corrected fasting glucose and hemoglobin A1c (HbA1c) were observed in patients with T2DM who received dulaglutide 0.75 mg and 1.5 mg.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  16. 16HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with diabetes, dulaglutide 0.75 mg significantly reduced baseline-corrected HbA1c.

    In plain wordsIn Chinese patients with diabetes, HbA1c fell after dulaglutide 0.75 mg.

    Outcome
    DecreaseHbA1c at 0.75 mg
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant reductions in baseline-corrected fasting glucose and hemoglobin A1c (HbA1c) were observed in patients with T2DM who received dulaglutide 0.75 mg and 1.5 mg.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  17. 17HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with diabetes, dulaglutide 1.5 mg significantly reduced baseline-corrected HbA1c.

    In plain wordsIn Chinese patients with diabetes, HbA1c fell after dulaglutide 1.5 mg.

    Outcome
    DecreaseHbA1c at 1.5 mg
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.5 mg weekly · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant reductions in baseline-corrected fasting glucose and hemoglobin A1c (HbA1c) were observed in patients with T2DM who received dulaglutide 0.75 mg and 1.5 mg.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  18. 18HumanRandomized controlled trialSafety outcome

    In healthy Chinese subjects and patients with diabetes, dulaglutide was well tolerated.

    In plain wordsIn healthy Chinese subjects and patients with diabetes, dulaglutide was well tolerated.

    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Dulaglutide was well tolerated, with the majority of adverse events being gastrointestinal disorders of mild severity.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.
  19. 19HumanRandomized controlled trialSafety outcome

    In healthy Chinese subjects and patients with type 2 diabetes given dulaglutide, most adverse events were mild gastrointestinal disorders.

    In plain wordsIn healthy Chinese subjects and patients with diabetes given dulaglutide, most side effects were mild digestive problems.

    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Dulaglutide was well tolerated, with the majority of adverse events being gastrointestinal disorders of mild severity.
    3 context sentences
    Summary · context
    This study evaluated the pharmacokinetics, pharmacodynamics, and safety of a single dulaglutide dose in Chinese healthy subjects and of multiple dulaglutide doses in Chinese patients with type 2 diabetes mellitus (T2DM).
    Summary · context
    This two-part, double-blind, placebo-controlled study included 16 healthy subjects randomized to receive a single dose of placebo and two of three dulaglutide doses (0.5 mg, 0.75 mg, or 1.5 mg) in three treatment periods,
    Summary · context
    and 42 patients with T2DM randomized to receive placebo or one of the three dulaglutide doses once weekly for 4 weeks.

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 1Results postedNCT01667900

A Study of Dulaglutide in Chinese Participants

Eli Lilly and Companyn = 58Aug 2012 to Jun 2014

Diabetes Mellitus, Type 2 · Healthy Volunteers

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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