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 |
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
- 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
We found this trial at
67
sites
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