Overview

A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
2,4-thiazolidinedione
Biguanides
Dulaglutide
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Criteria
Inclusion Criteria:

- Participants who have had a diagnosis of type 2 diabetes mellitus before screening

- Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG,
TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been
on a stable dose for at least 8 weeks before screening

- Participants must have a qualifying HbA1c value of 7.0% to 11.0% 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 within the 3 months before screening

- Participants who are currently taking insulin or have had previous insulin treatment
within the 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)