Overview

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Dulaglutide
Immunoglobulin Fc Fragments
Insulin
Insulin Glargine
Insulin, Globin Zinc
Metformin
Criteria
Inclusion Criteria:

- Have type 2 diabetes mellitus for at least 6 months

- Have been taking metformin and/or a sulfonylurea for at least 3 months before
screening and have been on a stable therapeutic dose for at least 8 weeks

- Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%

- Adult men or adult non-pregnant, non-breastfeeding women

- Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)

- Stable weight (±5%) ≥3 months prior to screening

Exclusion Criteria:

- Have type 1 diabetes mellitus

- Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1
analog, or any other incretin mimetic

- Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase
inhibitor (AGI), thiazolidinedione (TZD), or glinide

- Have gastric emptying abnormality

- Have cardiac disorder defined as unstable angina, myocardial infarction, coronary
artery bypass graft surgery, percutaneous coronary intervention, heart failure,
arrhythmia, transient ischemic attack, or stroke

- Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of
mercury[mmHg] or diastolic blood pressure above 95 mmHg)

- Have impaired liver function

- Have impaired kidney function

- Have history of chronic pancreatitis or acute pancreatitis

- Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)

- Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia,
carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)