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Completed

NCT Number: NCT03315780

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

    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

  1. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, 4 Weeks

    Change from baseline in fasting blood glucose obtained at pre-meal.

  2. Change From Baseline in Postprandial Blood Glucose

    Time frame: Baseline, 4 Weeks

    Change from baseline in postprandial blood glucose at 120 minutes at week 4.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. Number of Participants Who Develop Hypoglycemic Events

    Time frame: Baseline through 4 weeks

    Number of participants who develop hypoglycemic events.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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