A Study in Patients With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 2011
End Date:January 2014

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A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study

The purpose of this study is:

- To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of
treatment.

- To compare the rate of night time low blood sugar episodes on LY2605541 with insulin
glargine during 52 weeks of treatment.

- To compare the number of participants on LY2605541 reaching blood sugar targets without
low blood sugar episodes at night to those taking insulin glargine after 52 weeks of
treatment.

- To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after
52 weeks of treatment


Inclusion Criteria:

- Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to
the study

- Have been receiving at least 2 OAMs for at least 3 months before entering the study

- Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening

- Are capable of and willing to inject insulin with a vial and syringe and perform self
blood glucose monitoring

- Women of childbearing potential only: are not breastfeeding, have a negative pregnancy
test at the time of screening and randomization, intend to not become pregnant during
the trial, have practiced a reliable method of birth control for at least 6 weeks
prior to screening, and agree to use a reliable method of birth control during the
study and until 2 weeks following the last dose of study drug

Exclusion Criteria:

- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except
for short-term treatment of acute conditions, and up to a maximum of 4 continuous
weeks

- Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist
(for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within
3 months prior to screening

- Are currently taking, or have taken within the 3 months preceding screening,
medications to promote weight loss

- Have had any episodes of severe hypoglycemia within 6 months prior to screening

- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months
prior to the study

- Have cardiac disease with functional status that is New York Heart Association Class
III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)

- Have a history of renal transplantation, or are currently receiving renal dialysis or
have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)

- Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic
fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic
steatohepatitis (NASH), or elevated liver enzyme measurements at screening

- Have had a blood transfusion or severe blood loss within 3 months prior to screening
or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other
traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c

- Have active or untreated malignancy or have been in remission from clinically
significant malignancy for less than 5 years

- Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5
millimoles per liter [mmol/L]) at screening

- Are using lipid-lowering medication at a dose that has not been stable for 90 days
prior to screening

- Are using niacin preparations as a lipid lowering medication and bile acid
sequestrants within 90 days prior to screening
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