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

Use our guide to learn which trials are right for you!

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
We found this trial at
34
sites
?
mi
from
Beroun,
Click here to add this to my saved trials
898
mi
from
Akron, OH
Click here to add this to my saved trials
522
mi
from
Austin, TX
Click here to add this to my saved trials
1575
mi
from
Bangor, ME
Click here to add this to my saved trials
615
mi
from
Bloomington, IN
Click here to add this to my saved trials
780
mi
from
Bountiful, UT
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
154
mi
from
Concord, CA
Click here to add this to my saved trials
591
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Delaware, OH
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
1127
mi
from
Escondido, CA
Click here to add this to my saved trials
1403
mi
from
Federal Way, WA
Click here to add this to my saved trials
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
518
mi
from
Jackson, TN
Click here to add this to my saved trials
467
mi
from
Memphis, TN
Click here to add this to my saved trials
841
mi
from
Mesa, AZ
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
630
mi
from
Milwaukee, WI
Click here to add this to my saved trials
1425
mi
from
Nashua, NH
Click here to add this to my saved trials
1091
mi
from
New Port Richey, FL
Click here to add this to my saved trials
1427
mi
from
Olympia, WA
Click here to add this to my saved trials
1145
mi
from
Oviedo, FL
Click here to add this to my saved trials
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1064
mi
from
Raleigh, NC
Click here to add this to my saved trials
1121
mi
from
Rockville, MD
Click here to add this to my saved trials
797
mi
from
Roswell, GA
Click here to add this to my saved trials
499
mi
from
Round Rock, TX
Click here to add this to my saved trials
Spring Valley, California 91978
1133
mi
from
Spring Valley, CA
Click here to add this to my saved trials
251
mi
from
Springfield, MO
Click here to add this to my saved trials
1276
mi
from
Toms River, NJ
Click here to add this to my saved trials
144
mi
from
Topeka, KS
Click here to add this to my saved trials