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Completed

NCT Number: NCT04809220

A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemic Agents Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus (T2DM)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nakayama Clinic, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
  • Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
  • Have the following HbA1c result at screening.
  • Participants taking DPP-4i: ≥7.5% and ≤9.5%,
  • Participants taking another OAM: ≥8.0% and ≤10.0%
  • Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
  • Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion criteria

  • Have type 1 diabetes (T1D)
  • Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
  • Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
  • Have a known clinically significant gastric empty abnormality
  • Have acute or chronic hepatitis
  • Have had chronic or acute pancreatitis
  • Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
  • Have evidence of significant, active autoimmune abnormality
  • Have evidence of significant, uncontrolled endocrine abnormality
  • Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
  • Have any hematologic condition that may interfere with HbA1c measurement

Treatment and study plan

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Oral antihyperglycemics

Drug

Administered orally

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

    Time frame: Baseline, Week 26

    HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.

Secondary outcomes

  1. Change From Baseline in HbA1c at Week 52

    Time frame: Baseline, Week 52

    HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.

  2. Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

    Time frame: Week 52

    HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.

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

    Time frame: Baseline, Week 52

    FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.

  4. Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

    Time frame: Baseline, Week 26

    SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.

  5. Change From Baseline in Body Weight

    Time frame: Baseline, Week 52

    LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Two Doses of Dulaglutide in Combination With a Single Oral Antihyperglycemic Medication or as Monotherapy in Japanese Patients With Type 2 Diabetes Mellitus (AWARD-JPN: Assessment of Weekly Administration of LY2189265 in Diabetes - JAPAN)

Acronym: AWARD-JPN

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 22, 2021
Registry last updated
May 22, 2024

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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