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Study · Randomized controlled trial · n = 361 · 2015

5 results

Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study.

Araki E, Inagaki N, Tanizawa Y, Oura T, Takeuchi M, Imaoka T

Diabetes, obesity & metabolism20 Aug 2015Cited by 70 (Europe PMC)

PMID26179754 (opens in a new tab)PMCIDPMC5042081 (opens in a new tab)DOI10.1111/dom.12540 (opens in a new tab)PepBankPUB-26179754
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide reduced HbA1c more than glargine at week 26.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide lowered HbA1c more than glargine at week 26.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c
    Study

    n = 361

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

    Measurements

    HbA1c difference
    −0.54%
    versus glargine
    HbA1c change
    −1.44%
    dulaglutide
    HbA1c change
    −0.9%
    glargine

    Source sentences

    Summary
    The mean between-group treatment difference in HbA1c was -0.54% (95% CI -0.67, -0.41) [-5.90 mmol/mol (95% CI -7.32, -4.48)]; p < 0.001.
    4 context sentences
    Summary · context
    At week 26, least-squares (LS) mean (standard error) reductions in HbA1c were -1.44 (0.05)% [-15.74 (0.55) mmol/mol] in the dulaglutide group and -0.90 (0.05)% [-9.84 (0.55) mmol/mol] in the glargine group.
    Summary · context
    The primary measure was change from baseline in HbA1c at 26 weeks, analysed using a mixed-effects model for repeated measures, with a predefined non-inferiority margin of 0.4%.
    Summary · context
    To evaluate 0.75 mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).
    Summary · context
    In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with type 2 diabetes, dulaglutide reduced body weight more than glargine.

    In plain wordsIn Japanese patients with type 2 diabetes, dulaglutide reduced weight more than glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseBody weight
    Study

    n = 361

    Comparator
    insulin glargine
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.75 mg weekly · 26 weeksAs given in this study (human).

    Measurements

    Weight difference
    −1.42 kg
    versus glargine

    Source sentences

    Summary
    Dulaglutide significantly reduced body weight compared with glargine at week 26 (LS mean difference -1.42 kg, 95% CI -1.89, -0.94; p < 0.001).
    2 context sentences
    Summary · context
    To evaluate 0.75 mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).
    Summary · context
    In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine.
  3. 03HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, hypoglycaemia was less common with dulaglutide than glargine.

    In plain wordsIn Japanese patients with type 2 diabetes, low blood sugar was less common with dulaglutide than glargine.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHypoglycaemia
    Study

    n = 361

    Comparator
    insulin glargine
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.75 mg weekly · 26 weeksAs given in this study (human).

    Measurements

    Hypoglycaemia incidence
    26%
    dulaglutide
    Hypoglycaemia events
    47 patients
    dulaglutide
    Hypoglycaemia incidence
    48%
    glargine
    Hypoglycaemia events
    86 patients
    glargine

    Source sentences

    Summary
    The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001.
    2 context sentences
    Summary · context
    To evaluate 0.75 mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).
    Summary · context
    In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine.
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, nasopharyngitis was among the most frequent adverse events with dulaglutide.

    In plain wordsIn Japanese patients with type 2 diabetes, nasopharyngitis was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableNasopharyngitis
    Study

    n = 181

    Outcome group
    Adverse events · Respiratory
    Studied dose
    0.75 mg weekly · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse events with dulaglutide treatment were nasopharyngitis and gastrointestinal symptoms.
    3 context sentences
    Summary · context
    The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001.
    Summary · context
    To evaluate 0.75 mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).
    Summary · context
    In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine.
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese patients with type 2 diabetes, gastrointestinal symptoms were among the most frequent adverse events with dulaglutide.

    In plain wordsIn Japanese patients with type 2 diabetes, digestive symptoms were frequent adverse events with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableGastrointestinal symptoms
    Study

    n = 181

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg weekly · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse events with dulaglutide treatment were nasopharyngitis and gastrointestinal symptoms.
    3 context sentences
    Summary · context
    The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001.
    Summary · context
    To evaluate 0.75 mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).
    Summary · context
    In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine.

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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