A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

Eli Lilly and Company145 enrolled

Overview

The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

145

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2189265DRUG

Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.

PlaceboDRUG

Administered by SC injection, QW for 12 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m\^2) but \<40.0 kg/m\^2. * Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD. * Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%. * Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening. Exclusion Criteria: * Patients who are currently taking prescription medications to promote weight loss * Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening. * Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility. * Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension. * Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range. * Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.

Locations (6)

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.

Chiba, Japan

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.

Time frame: Baseline, 12 weeks

Secondary Outcomes

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks

Percentage of participants who achieved HbA1c\<7% up to the 12-week endpoint.

Time frame: up to 12 weeks

Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks

Percentage of participants achieving HbA1c\<6.5% up to the 12-week endpoint.

Time frame: up to 12 weeks

Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks

Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.

Time frame: Baseline, 12 weeks

Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks

SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose\*visit, where the participant was treated as a random effect.

Data from ClinicalTrials.gov

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