An Individualized treatMent aPproach for oldER patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus - IMPERIUM

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 16.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-001473-24-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 880

Inclusion Criteria

The study will include patients who are:
•Patients with T2DM based on a history and clinical impression that is consistent with the World Health Organization [WHO] Classification of Diabetes
•Male or female
•Are at least 65 years of age at the time of screening
•Have a CFS of 4 or above AND/OR TIBI score of 5 or above as assessed at Visit 1
•Have an A1c >7.3% and <10.9% at study entry and are not achieving desired glycemic control as evidenced by A1c measurement at least 0.4% higher than individualized treatment target set at Visit 1.
•Have been treated for at least 3 months prior to the study entry with any of the following treatment options:
odiet/exercise only (only if they have known contraindications to metformin treatment)
oany dose of sulfonylurea
oeffective or maximally tolerated doses of metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual combination. The following doses are considered to be effective:
?at least 1500 mg of metformin per day
?at least 30 mg of pioglitazone per day
?at least 4 mg of rosiglitazone per day
?at least 75 mg of acarbose per day
?any marketed dose of DPP-4 inhibitor

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 970

Exclusion Criteria

Patients will be excluded from the study based on the following criteria:
•Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
•Are Lilly employees or are employees of third-party organizations (TPOs) involved in study who require exclusion of their employees
•Are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
•Have participated, within the last 60 days in a clinical trial involving an investigational product other than the investigational product used in this study. If the previous investigational product has a long half life, 3 months or 5 half-lives (whichever is longer) should have passed
•Have previously completed or withdrawn from this study. This exclusion criterion does not apply to patients who are rescreened prior to randomization.
•At study entry have contraindications to sulfonylurea, insulin, or GLP-1 RA
•Have a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2
•Have taken any injectable glucose-lowering agent, miglitol, meglitinide, Sodium/Glucose cotransporter-2 inhibitor, or other antihyperglycemia treatment that is not listed in inclusion criterion [6] (main protocol) for more than 10 days within 3 months prior to the study entry
•In the opinion of investigator should have an individualized A1c target set at 8% or higher
•Have a BMI greater than 45 kg/m2
•Have had more than 1 episode of severe hypoglycemia within 24 weeks prior to the study
•Have cardiac disease with functional status that is Class III or IV according to the New York Heart Association Cardiac Disease Classification
•Have an eGFR<30 mL/min/1.73 m2 or advanced renal disease including history of renal transplantation or currently receiving renal dialysis
•Have obvious clinical signs or symptoms or laboratory evidence of liver disease (alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of the reference range)
•Receive current therapy for a malignancy, other than basal-cell or squamous-cell skin cancer
•Received systemic glucocorticoids within the 3 months prior to entry for more than 14 consecutive days.
•Have any other condition that precludes the patient from following and completing the protocol.