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Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

NCTNCT02750410 (opens ClinicalTrials.gov in a new tab)Other id15803Other idH9X-JE-GBGF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
159 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Aug 2016
Primary completion
18 Jun 2018
Completion
18 Jun 2018
First posted
25 Apr 2016 (estimated)
Last update posted
24 Sept 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 4

    A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

    NCT02750410

    Aug 2016 to 18 Jun 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Interventions

  • DulaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Dulaglutide

    Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.

  • Placebo comparator

    Placebo

    Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 16

    Registry description

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

Secondary outcomes(5)

  1. Percentage of Participants With HbA1c <7.0% or ≤6.5%

    Time frame · Week 16

    Registry description

    Percentage of participants whose HbA1c was \<7.0% or ≤6.5%. HbA1c \<7.0% is presented.

  2. Change From Baseline in Fasting Serum Glucose (FSG)

    Time frame · Baseline, Week 16

    Registry description

    The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (\<8.5%, \>=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

  3. Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

    Time frame · Baseline, Week 16

    Registry description

    The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (\<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).

  4. Change From Baseline in Body Weight

    Time frame · Baseline, Week 16

    Registry description

    LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (\<8.5%, \>=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

  5. Change From Baseline in Daily Total Insulin Dose

    Time frame · Baseline, Week 16

    Registry description

    Mean change from baseline in total insulin dose was measured in each treatment groups.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 16

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (percentage of HbA1c)Spread
Placebo0.060.099
Dulaglutide-1.450.057
Secondary and other outcome results(5)
Secondary outcomeNumber· Week 16

Percentage of Participants With HbA1c <7.0% or ≤6.5%

GroupValue (percentage of participants)
Placebo47.4
Dulaglutide0
Secondary outcomeLeast squares mean· Baseline, Week 16

Change From Baseline in Fasting Serum Glucose (FSG)

GroupValue (milligram/deciliter (mg/dL))Spread
Placebo-4.14.94
Dulaglutide-34.22.78
Secondary outcomeLeast squares mean· Baseline, Week 16

Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)

GroupValue (mg/dL)Spread
Placebo12.304.37
Dulaglutide-14.282.52
Secondary outcomeLeast squares mean· Baseline, Week 16

Change From Baseline in Body Weight

GroupValue (kilogram (kg))Spread
Placebo-0.300.302
Dulaglutide-0.200.171
Secondary outcomeMean· Baseline, Week 16

Change From Baseline in Daily Total Insulin Dose

GroupValue (International Units (IU)/Day)Spread
Placebo-0.31.2
Dulaglutide-1.13.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo Double-Blind (DB) Treatment PeriodPlacebo administered SC once weekly for 16 weeks.0 / 390 / 3918 / 39
Dulaglutide 0.75 mg DB Treatment PeriodDulaglutide 0.75 mg administered SC once weekly for 16 weeks.0 / 1203 / 12047 / 120
Placebo DB Treatment, Dulaglutide 0.75 mg Extension PeriodPlacebo administered SC once weekly for 16 weeks then Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.0 / 391 / 3928 / 39
Dulaglutide 0.75 mg DB Treatment/Extension PeriodDulaglutide 0.75 mg administered SC once weekly for 52 weeks.0 / 1206 / 12059 / 120

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 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 et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10

PMID 31758520PMC6965529DOI 10.1007/s13300-019-00726-8PUB-31758520

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

PubMed tag: none · 2020

8 results

Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen.

Onishi et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 2

PMID 31994009PMC7048887DOI 10.1007/s13300-020-00765-6PUB-31994009

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus * Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening * Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 \[DPP-4\] inhibitors, sulfonylurea \[SU\], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs * Participants who have stable weight (±5%) ≥3 months prior to screening * Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Participants who have a diagnosis of type 1 diabetes * Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening * Participants who have been previously treated with dulaglutide prior to screening * Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide) * Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening * Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities * Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy

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