Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

NCTNCT03315780Other id16730Other idH9X-JE-GBGK

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 12 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Single masking
Countries: 1 country
Japan
Start: 28 Oct 2017
Primary completion: 28 Feb 2018
Completion: 28 Feb 2018
First posted: 20 Oct 2017
Last update posted: 16 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

201720182019

Ph 4
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
NCT03315780
28 Oct 2017 to 28 Feb 2018

Registry summary

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

The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

Interventions

DulaglutideDrug
PlaceboDrug

Arms2

Experimental
Dulaglutide, Placebo
Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.
Experimental
Placebo, Dulaglutide
Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])
Time frame · Baseline, 4 Weeks
Registry description
Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect.

Secondary outcomes(7)

Change From Baseline in Fasting Blood Glucose
Time frame · Baseline, 4 Weeks
Registry description
Change from baseline in fasting blood glucose obtained at pre-meal.
Change From Baseline in Postprandial Blood Glucose
Time frame · Baseline, 4 Weeks
Registry description
Change from baseline in postprandial blood glucose at 120 minutes at week 4.
Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
Time frame · Baseline, 4 Weeks
Registry description
LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.
Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
Time frame · Baseline, 4 Weeks
Registry description
LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.
Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
Time frame · Baseline, 4 Weeks
Registry description
LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.
Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])
Time frame · Baseline, 4 Weeks
Registry description
LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.
Number of Participants Who Develop Hypoglycemic Events
Time frame · Baseline through 4 weeks
Registry description
Number of participants who develop hypoglycemic events.

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, 4 Weeks

Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])

Group	Value (milligramhour per deciliter (mgh/dL))
Dulaglutide	-238.46
Placebo	15.56

Secondary and other outcome results(7)

Secondary outcomeMean· Baseline, 4 Weeks

Change From Baseline in Fasting Blood Glucose

Group	Value (milligrams per deciliter (mg/dL))	Spread
Dulaglutide	-39.8	33.3
Placebo	-8.2	21.5

Secondary outcomeMean· Baseline, 4 Weeks

Change From Baseline in Postprandial Blood Glucose

Group	Value (mg/dL)	Spread
Dulaglutide	-67.0	32.1
Placebo	13.9	28.7

Secondary outcomeLeast squares mean· Baseline, 4 Weeks

Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Group	Value (insulin unitsh/mL (µUh/mL))
Dulaglutide	25.20
Placebo	-2.27

Secondary outcomeLeast squares mean· Baseline, 4 Weeks

Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Group	Value (nanogramh/milliliter (ngh/mL))
Dulaglutide	3.58
Placebo	-0.14

Secondary outcomeLeast squares mean· Baseline, 4 Weeks

Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Group	Value (picomoleh/Liter (pmolh/L))
Dulaglutide	-16.39
Placebo	-7.02

Secondary outcomeLeast squares mean· Baseline, 4 Weeks

Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])

Group	Value (mg*h/dL)
Dulaglutide	31.02
Placebo	46.41

Secondary outcomeCount of participants· Baseline through 4 weeks

Number of Participants Who Develop Hypoglycemic Events

Group	Value (Participants)
Dulaglutide	0
Placebo	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
DulaglutideDulaglutide 0.75 mg administered SC once weekly for four weeks.	0 / 12	0 / 12	5 / 12
PlaceboPlacebo administered SC once weekly for four weeks.	0 / 12	0 / 12	4 / 12

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2019

7 results

Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial.

Inoue et al. 2019Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10

PMID 30949907PMC6531535DOI 10.1007/s13300-019-0605-7PUB-30949907

Free to read · publisher termsCC BY-NC7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Have type 2 diabetes (based on the World Health Organization \[WHO\] diagnostic criteria) for at least 1 year. * Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening). * Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening. * Have a screening body weight of ≥50 and ≤80 kilograms. Exclusion Criteria: * Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists. * Have had a clinically significant cardiovascular disease. * Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery. * Have acute or chronic hepatitis, signs and symptoms of any other liver disease. * Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis. * Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 meter squared. * In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

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