A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2189265; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001104

12840

H9X-JE-GBCZ (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 145 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

145 participants in 4 patient groups, including a placebo group

0.75 mg LY2189265

Experimental group

Treatment:

Drug: LY2189265

0.5 mg LY2189265

Experimental group

Treatment:

Drug: LY2189265

0.25 mg LY2189265

Experimental group

Treatment:

Drug: LY2189265

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo