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Study · Randomized controlled trial · 2014

12 results

Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study.

Terauchi Y, Satoi Y, Takeuchi M, Imaoka T

Endocrine journal17 Jul 2014Cited by 41 (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 study12

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide 0.25 mg reduced HbA1c versus placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide 0.25 mg lowered HbA1c versus placebo.

    Outcome
    DecreaseHbA1c
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.25 mg weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    HbA1c difference
    −0.72%
    versus placebo

    Source sentences

    Summary
    Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p<0.001.
    2 context sentences
    Summary · context
    The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks.
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide 0.5 mg reduced HbA1c versus placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide 0.5 mg lowered HbA1c versus placebo.

    Outcome
    DecreaseHbA1c
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.5 mg weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    HbA1c difference
    −0.97%
    versus placebo

    Source sentences

    Summary
    Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p<0.001.
    2 context sentences
    Summary · context
    The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks.
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide 0.75 mg reduced HbA1c versus placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide 0.75 mg lowered HbA1c versus placebo.

    Outcome
    DecreaseHbA1c
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    HbA1c difference
    −1.17%
    versus placebo

    Source sentences

    Summary
    Significant dose-dependent reductions in HbA1c were observed (least squares mean difference versus placebo [95% confidence interval]): DU 0.25=-0.72% (-0.95, -0.48), DU 0.5=-0.97% (-1.20, -0.73), and DU 0.75=-1.17% (-1.41, -0.93); p<0.001.
    2 context sentences
    Summary · context
    The primary measure was change from baseline in glycated haemoglobin (HbA1c; %) at 12 weeks.
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide improved fasting plasma glucose versus placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide improved fasting blood glucose versus placebo.

    Outcome
    DecreaseFasting plasma glucose
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant improvements in plasma glucose (PG), both fasting and average 7-point self-monitored blood glucose, were also observed with dulaglutide versus placebo (p<0.001).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide improved average 7-point self-monitored glucose versus placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide improved average self-monitored glucose versus placebo.

    Outcome
    DecreaseAverage 7-point self-monitored glucose
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant improvements in plasma glucose (PG), both fasting and average 7-point self-monitored blood glucose, were also observed with dulaglutide versus placebo (p<0.001).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, dulaglutide was well tolerated.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide was well tolerated.

    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Dulaglutide was well-tolerated.
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, gastrointestinal adverse events were more common with dulaglutide than placebo.

    In plain wordsIn Japanese patients with type 2 diabetes, digestive adverse events were more common with dulaglutide than placebo.

    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal adverse events (AEs) were more common in dulaglutide-treated patients, with nausea the most frequent (8 [5.5%]).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, nausea was the most frequent gastrointestinal adverse event with dulaglutide.

    In plain wordsIn Japanese patients with type 2 diabetes, nausea was the most frequent digestive adverse event with dulaglutide.

    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Nausea events
    8 patients
    reported in abstract
    Nausea incidence
    5.5%
    reported in abstract

    Source sentences

    Summary
    Gastrointestinal adverse events (AEs) were more common in dulaglutide-treated patients, with nausea the most frequent (8 [5.5%]).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, 4 dulaglutide-treated patients discontinued because of adverse events.

    In plain wordsIn Japanese patients with type 2 diabetes, 4 dulaglutide-treated patients stopped treatment because of adverse events.

    Outcome
    Not applicableDiscontinuation due to adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Discontinuations
    4 patients
    dulaglutide
    Discontinuations
    3.7%
    dulaglutide

    Source sentences

    Summary
    Few dulaglutide-treated patients discontinued due to AEs (4 [3.7%]), and no serious AEs related to study medication occurred.
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  10. 10HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, no serious adverse events related to dulaglutide occurred.

    In plain wordsIn Japanese patients with type 2 diabetes, no serious adverse events related to dulaglutide occurred.

    Outcome
    Not applicableDrug-related serious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Few dulaglutide-treated patients discontinued due to AEs (4 [3.7%]), and no serious AEs related to study medication occurred.
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  11. 11HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, one patient receiving dulaglutide 0.5 mg reported asymptomatic hypoglycaemia.

    In plain wordsIn Japanese patients with type 2 diabetes, one patient receiving dulaglutide 0.5 mg reported low blood sugar without symptoms.

    Outcome
    Not applicableAsymptomatic hypoglycaemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.5 mg weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia events
    1 patient
    DU 0.5

    Source sentences

    Summary
    Three patients (DU 0.5=1 and DU 0.75=2) reported asymptomatic hypoglycaemia (PG ≤70 mg/dL).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).
  12. 12HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, two patients receiving dulaglutide 0.75 mg reported asymptomatic hypoglycaemia.

    In plain wordsIn Japanese patients with type 2 diabetes, two patients receiving dulaglutide 0.75 mg reported low blood sugar without symptoms.

    Outcome
    Not applicableAsymptomatic hypoglycaemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia events
    2 patients
    DU 0.75

    Source sentences

    Summary
    Three patients (DU 0.5=1 and DU 0.75=2) reported asymptomatic hypoglycaemia (PG ≤70 mg/dL).
    1 context sentence
    Summary · context
    In this randomised, double-blind, placebo-controlled, parallel-group, 12-week study, patients received once weekly subcutaneous dulaglutide doses of 0.25, 0.5, or 0.75 mg (DU 0.25, DU 0.5, and DU 0.75, respectively) or placebo (n=36, 37, 35, and 37, respectively).

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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

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