A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:May 2012
End Date:December 2013

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A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study

The purpose of this study is to compare LY2605541 and insulin glargine using the following
measures after participants have been treated for 26 weeks:

- Change in participants' overall blood sugar control

- The rate of night time low blood sugar episodes

- The number of participants that reach blood sugar targets without low blood sugar
episodes at night

- The rate of low blood sugar episodes reported over a 24-hour period


Inclusion Criteria:

- Have had type 2 diabetes mellitus for at least 1 year

- Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or
glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used
as specified in the local prescribing information for at least 90 days prior to
screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily
dose allowed by local regulations or at the maximally tolerated dose

- Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening

- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter
(kg/m^2)

- Women of childbearing potential who are not breastfeeding, have a negative pregnancy
test at screening and randomization, do not plan to become pregnant during the study,
and have practiced reliable birth control for at least 6 weeks prior to screening and
will continue to do so during the study and until 2 weeks after the last dose of study
drug

Exclusion Criteria:

- Have routinely used insulin glargine twice daily in the 90 days prior to the study or
have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past
6 months, except for short-term treatment up to a maximum of 4 continuous weeks

- Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist
concurrently or within 90 days prior to screening

- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic
diseases in the local product regulations

- Are taking, or have taken within the 90 days preceding screening, prescription or
over-the-counter 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 diabetic ketoacidosis or hyperosmolar state/coma in the
6 months prior to screening

- Have cardiac disease with functional status that is New York Heart Association Class
III or IV

- Have a history of renal transplantation, or are currently receiving renal dialysis or
have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177
micromoles per liter [µmol/L])

- 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

- 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 cancer, have been in remission from clinically significant
cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or
are at increased risk for developing cancer or a recurrence of cancer in the opinion
of the investigator

- Are receiving chronic (lasting longer than 14 consecutive days) systemic
glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled
preparations) or have received such therapy within the 8 weeks immediately preceding
screening

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

- Have an irregular sleep/wake cycle (for example, participants who sleep during the day
and work during the night) in the investigator's opinion

- Lipid-lowering medication: Are using or have used any of the following:

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

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