The Effect the Study Drug has on the Heart in Patients with Type 2 Diabetes.
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Cardiovascular events in patients with Type 2 diabetesMedDRA version: 20.0Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 100000004860
- Registration Number
- EUCTR2010-023799-21-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9600
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Men or women with type 2 diabetes based on:
a) a previous diagnosis of type 2 diabetes; or
b) newly detected type 2 diabetes based on the American Diabetes Association criteria (ADA 2011) as either two of the following criteria or one of the following criteria that is confirmed on a second day:
- fasting plasma glucose =7.0 mmol/L (126 mg/dL), or
- 2-hour plasma glucose =11.1 mmol/L (200 mg/dL) following a
75-gram oral glucose load, as described by the World Health
Organization (WHO 2006), or
- HbA1c =6.5% (=48 mmol/mol)
[2] HbA1c value of =9.5% (=81 mmol/mol) at screening
[3] Are taking:
a) no glucose-lowering drugs; OR
b) 1 or 2 classes of oral glucose-lowering drugs; with or without 1 injection of basal insulin daily[as defined below in (d); if one of the oral glucose-lowering drugs is a DPP-IV inhibitor, the patient must be willing to stop the DPP-IV inhibitor after eligibility is confirmed; OR
c) 1 or 2 classes of oral glucose-lowering drugs with a GLP-1 analog; with or without basal insulin daily [as defined below in (d)]the patient must be willing to stop the GLP-1 analog after eligibility is confirmed; OR
d) basal insulin daily defined as 1 to 2 injections per day of either glargine, detemir, neutral protamine Hagedorn (NPH), or another approved basal insulin
[4] No change in the number or class of glucose-lowering drugs, no change in excess of doubling or halving the dose of these drugs, and if on insulin no change in the dose of insulin in excess of 20% of the average daily dose, for at least 3 months before screening
[5] If age =50 years and established clinical vascular disease defined as 1 or more of the following:
- a history of MI
- a history of ischemic stroke
- a history of coronary, carotid, or peripheral artery revascularization. If
prior coronary artery bypass grafting (CABG), the CABG should have been performed >2 years prior to randomization.If prior carotid or peripheral artery revascularization, the revasculization should have been performed > 2 months prior to randomization.
- hospitalization for unstable angina with ECG changes (new or
worsening ST or T wave changes), or myocardial ischemia on
imaging, or need for percutaneous coronary intervention (PCI);
OR
- If age =55 years and subclinical vascular disease defined as 1 or more of the following:
- a history of myocardial ischemia by a stress test or with cardiac
imaging, with or without history of exertional angina
- >50% vascular stenosis with imaging of the coronary, carotid, or lower extremity arteries, with or without claudication history
- ankle-brachial index <0.9
- 2 consecutive values or a documented history of persistent eGFR<60 mL/minute/1.73m2
- a history of hypertension with documented LV hypertrophy on an
ECG or echocardiogram
- documented history of persistent microalbuminuria or macroalbuminuria or 2 consecutive urine samples demonstrating micro- or macroalbuminuria;
OR
- If age =60 years and at least 2 or more of the following risk factors for CV outcomes:
- current tobacco use (any form of tobacco)
- use at least 1 approved lipid modifying therapy to treat
-hepercholesterolemia or a documented untreated low-density lipoprotein cholesterol (LDL-C) =3.4 mmol/L (130 mg/dL) within the past 6 months
- documented treated or untreated high-density lipoprotein cholesterol (HDL-C)
<1.0 mmol/L (40 mg/d
Patients will be excluded from the study if they meet any of the following criteria:
[1] Uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician.
[2] Have experienced a severe hypoglycemic episode within 1 year prior to randomization.
[3] Have experienced an acute coronary or cerebrovascular event within 2 months prior to randomization.
[4] Are currently planning a coronary, carotid, or peripheral artery
revascularization.
[5] Have known chronic renal failure (defined as a known eGFR
<15 mL/minute/1.73m2) or are on chronic dialysis at screening.
[6] Have a known clinically significant gastric emptying abnormality (for
example, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (such as bariatric) surgery.
[7] Have a past history of chronic, acute, or idiopathic pancreatitis or
signs/symptoms of pancreatitis.
[8] Have severe hepatic dysfunction such as portal hypertension or cirrhosis, acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine transaminase (ALT) level =3.0 times the upper limit of normal (ULN) for the reference range at screening.
[9] Have a) any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of multiple endocrine neoplasia MEN 2A or 2B syndrome), or
b) any known self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia. This includes patients with a family history of MEN 2A or 2B whose family history for the syndrome is RET negative. The only exception for this exclusion will be patients whose family members with MEN 2A or 2B have a known RET mutation and the potential patient for the study is negative for that RET mutation.
[10] Have a calcitonin value =20 pg/mL according to the central laboratory measurement at screening.
[11] Are previous organ transplant recipients or are awaiting an organ transplant (corneal transplants [keratoplasty] are allowed).
[12] Are taking a weight loss drug (over-the-counter or prescription) and are unwilling or unable to discontinue the drug at the time of screening or are taking pramlintide at the time of screening.
[13] History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening.
[14] Females who are pregnant or have a positive pregnancy test at screening, or who have given birth within the past 90 days, or who are breastfeeding.
[15] Females of childbearing potential (that is, females who are between menarche and less then 1-year past the last menses with an intact uterus) and who do not agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Menopause is the absence of menses for = 1 year and/or surgically or chemically inducted.
[16] Are medically unstable with life expectancy <1 year.
[17] Are unwilling to permit sites to contact their primary physicians to
communicate information about the study and the patient’s data.
[18] In the judgment of the investigator, have any other condition likely to limit protocol compliance or reporting
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method