A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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0.75 mg LY2189265

Group Type EXPERIMENTAL

LY2189265

Intervention Type DRUG

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

0.5 mg LY2189265

Group Type EXPERIMENTAL

LY2189265

Intervention Type DRUG

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

0.25 mg LY2189265

Group Type EXPERIMENTAL

LY2189265

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by SC injection, QW for 12 weeks.

Interventions

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LY2189265

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

Intervention Type DRUG

Placebo

Administered by SC injection, QW for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No