A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

Eli Lilly and Company361 enrolled

Overview

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \[OAM\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

361

Conditions

Type 2 Diabetes Mellitus

Interventions

LY2189265DRUG

Insulin glargineDRUG

Sulfonylureas (SU)DRUG

Biguanide (BG)DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening * Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable * Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at 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 been treated with any other glucagon-like peptide 1 (GLP-1) analog * Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening * Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening * Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening * Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)

Locations (15)

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.

Time frame: Baseline, 26 weeks

Secondary Outcomes

Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks

The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.

Time frame: Up to 26 weeks

Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks

Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.

Time frame: Baseline, 26 weeks

Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks

Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects and baseline SMBG as a covariate.

Data from ClinicalTrials.gov

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Aichi, Japan

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Hokkaido, Japan

Kagoshima, Japan

Kanagawa, Japan

Kumamoto, Japan

Kyoto, Japan

Nagano, Japan

...and 5 more locations