A Study in Type 2 Diabetes

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 14.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-001254-29-GR

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1325

Inclusion Criteria

[1]Have T2DM based on the World Health Organization (WHO) classification
[2] Are at least 18 years of age
[3] Duration of diabetes =1 year
[4] Have an HbA1c value =7.0% and <12.0% according to the central laboratory
at screening
[5] BMI =45.0 kg/m2
[6] Patients on any glucose lowering regimen that contains at least 1 injection of
insulin per day. Patients will take their last dose of antidiabetic medication with the exception of metformin the day prior to randomization.
[7] This inclusion criterion applies ONLY to women of childbearing potential.
•Are not breastfeeding.
•Test negative for pregnancy at the time of screening and time of randomization based on a serum pregnancy test.
•Do not intend to become pregnant during the study.
•Have practiced a reliable method of birth control (eg, use of oral contraceptives or levonorgestrel; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) 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).
[8] Have access to a method of communication with the site
[9] Have refrigeration in the home
[10] 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 patient visits 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.
[11] Have given written informed consent to participate in this study in accordance with local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 994
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 331

Exclusion Criteria

[12] Insulin pump therapy: Continuous subcutaneous insulin infusion therapy prior to screening.
[13] Twice daily insulin glargine: Are using twice daily insulin glargine prior to screening.
[14] Excessive insulin resistance: Defined as having received a daily dose of insulin = 2.0 units/kg at the time of pre-randomization.
[15] Concomitant medications: 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.
[16] Lipid-lowering medications: are using niacin preparations as a lipid lowering medication and 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. If a patient has not been on a stable dose of lipid-lowering medication for =90 days prior to screening, the site should wait to screen the patient. If the results of the screening laboratory tests require a change to the patient's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the patient and have the patient return =90 days
later to complete some of the screening procedures again.
[17] Triglycerides: Have fasting hypertriglyceridemia (defined as >4.5 mmol/L, >400 mg/dL) at screening, as determined by the central laboratory.
[18] Weight loss medications: Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss.
[19] Severe hypoglycemia history: 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.
[20] Glycemic control: Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening.
[21] Diabetic ketoacidosis: Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening.
[22] Cardiovascular: 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).
[23] Renal: Are currently receiving renal dialysis or have a serum creatinine =2.0 mg/dL, except for patients taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine.
[24] Hepatic: 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.
[25] Malignancy: 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 invest