A Study in Participants With Type 2 Diabetes Mellitus

Status:

COMPLETED

A Study in Participants With Type 2 Diabetes Mellitus

Lead Sponsor:

Eli Lilly and Company

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low bl...

Eligibility Criteria

Inclusion

Inclusion Criteria
Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
Had diabetes ≥1 year
Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
This inclusion criterion applies ONLY to women of childbearing potential
Are not breastfeeding
Test negative for pregnancy at screening and randomization
Do not intend to become pregnant during the study
Have practiced a reliable method of birth control for at least 6 weeks prior to screening
Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
Have access to a method of communication with the site
Have refrigeration in the home
Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
Have given written informed consent to participate in this study in accordance with local regulations
Exclusion Criteria
Continuous subcutaneous insulin infusion therapy prior to screening
Are using twice daily insulin glargine prior to screening
Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
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 as indicated below:
total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>2.5X ULN as defined by the central laboratory, or
aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \>2.5X ULN as defined by the central laboratory
Have active or untreated malignancy, have been in remission from clinically significant malignancy (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
Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients
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 HbA1c measurement
Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
Have had an organ transplant
Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol

Exclusion

Key Trial Info

Start Date :

December 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

1369 Patients enrolled

Trial Details

Trial ID

NCT01468987

Start Date

December 1 2011

End Date

August 1 2013

Last Update

April 17 2018

Active Locations (156)

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mobile, Alabama, United States, 36617

Tucson, Arizona, United States, 85724

Little Rock, Arkansas, United States, 72205

Anaheim, California, United States, 92801

Trial Details

Trial ID

NCT01468987

Start Date

December 1 2011

End Date

August 1 2013

Last Update

April 17 2018

Status: