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Study · Randomized controlled trial · n = 159 · 2020

9 results

Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study.

Ishii H, Onishi Y, Oura T, Takeuchi M

Diabetes therapy : research, treatment and education of diabetes and related disorders22 Nov 2019Cited by 10 (Europe PMC)

PMID31758520 (opens in a new tab)PMCIDPMC6965529 (opens in a new tab)DOI10.1007/s13300-019-00726-8 (opens in a new tab)PepBankPUB-31758520
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes on insulin, dulaglutide lowered HbA1c more than placebo.

    In plain wordsIn Japanese patients with diabetes taking insulin, dulaglutide lowered HbA1c more than placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseHbA1c change
    Study

    n = 159

    Comparator
    Placebo with background insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg once weekly · 16 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.45%
    dulaglutide
    HbA1c change
    0.06%
    placebo
    HbA1c difference
    −1.5%
    versus placebo

    Source sentences

    Summary
    The least-squares (LS) mean changes from baseline in HbA1c at week 16 were dulaglutide - 1.45% and placebo 0.06%.
    5 context sentences
    Summary · context
    The LS mean and 95% confidence interval for the difference were - 1.50% (- 1.73%, - 1.28%) and dulaglutide was superior to placebo.
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes on insulin, weight changes did not differ significantly between dulaglutide and placebo.

    In plain wordsIn Japanese patients with diabetes taking insulin, weight changes were similar with dulaglutide and placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeBody weight change
    Study

    n = 159

    Comparator
    Placebo with background insulin
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.75 mg once weekly · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no significant differences between treatment groups in changes from baseline in body weight and insulin dose.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with diabetes on insulin, insulin dose changes did not differ significantly between dulaglutide and placebo.

    In plain wordsIn Japanese patients with diabetes taking insulin, insulin dose changes were similar with dulaglutide and placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeInsulin dose change
    Study

    n = 159

    Comparator
    Placebo with background insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg once weekly · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no significant differences between treatment groups in changes from baseline in body weight and insulin dose.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, hypoglycemia incidence did not differ significantly between dulaglutide and placebo.

    In plain wordsIn Japanese patients with diabetes taking insulin, low blood sugar incidence did not differ significantly between dulaglutide and placebo.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeHypoglycemic events
    Study

    n = 159

    Comparator
    Placebo with background insulin
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.75 mg once weekly · 16 weeksAs given in this study (human).

    Measurements

    Hypoglycemia incidence
    42.5%
    dulaglutide
    Hypoglycemia incidence
    30.8%
    placebo

    Source sentences

    Summary
    The incidence rates of hypoglycemic events by week 16 were dulaglutide 42.5% and placebo 30.8% (P = 0.258).
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, nasopharyngitis was a frequently observed adverse event with dulaglutide.

    In plain wordsIn Japanese patients with diabetes taking insulin, nose and throat inflammation was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableNasopharyngitis
    Study

    n: not reported in source

    Outcome group
    Adverse events · Respiratory
    Studied dose
    0.75 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, constipation was a frequently observed adverse event with dulaglutide.

    In plain wordsIn Japanese patients with diabetes taking insulin, constipation was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableConstipation
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, abdominal discomfort was a frequently observed adverse event with dulaglutide.

    In plain wordsIn Japanese patients with diabetes taking insulin, abdominal discomfort was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableAbdominal discomfort
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, nausea was a frequently observed adverse event with dulaglutide.

    In plain wordsIn Japanese patients with diabetes taking insulin, nausea was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.75 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese patients with diabetes on insulin, decreased appetite was a frequently observed adverse event with dulaglutide.

    In plain wordsIn Japanese patients with diabetes taking insulin, decreased appetite was a frequent adverse event with dulaglutide.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableDecreased appetite
    Study

    n: not reported in source

    Outcome group
    Appetite and food intake · Metabolic and weight
    Studied dose
    0.75 mg once weeklyAs given in this study (human).

    Source sentences

    Summary
    The most frequently observed treatment-emergent adverse events in dulaglutide were nasopharyngitis, constipation, abdominal discomfort, nausea, and decreased appetite.
    4 context sentences
    Summary · context
    This phase 4, randomized, placebo-controlled, double-blind, and subsequent open-label study aimed to assess the efficacy and safety of once-weekly dulaglutide 0.75 mg in combination with insulin therapy in patients with T2DM.
    Summary · context
    Patients enrolled in this multicenter study were Japanese with T2DM who had inadequate glycemic control (HbA1c 7.5-10.5%) with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin) in combination with or without one or two oral antidiabetic agents (OADs).
    Summary · context
    Patients were randomized in a 3:1 ratio to dulaglutide or placebo.
    Summary · context
    The first 16 weeks was the double-blind period with stable insulin dosing, and patients taking placebo were switched to dulaglutide for an additional 36-week open-label period in which all patients took dulaglutide (52 weeks total).

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 4Results postedNCT02750410

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Eli Lilly and Companyn = 159Aug 2016 to 18 Jun 2018

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 24 Sept 2019

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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