The Effect the Study Drug has on the Heart in Patients with Type 2 Diabetes.
- Conditions
- Cardiovascular events in patients with Type 2 diabetesMedDRA version: 19.0Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2010-023799-21-BG
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 9901
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 basal
insulin daily [as defined below in (d)]; if one of the oral glucoselowering
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 revascularization 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 microor
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 of at least 1 approved lipid modifying therapy to treat
hypercholesterolemia 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/dL) for men and <1.3 mmol/L (50 mg/dL)
for women or triglyceri
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 than 1-year past the last menses with an intact
uterus) 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 induced.
[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 of AEs (for example, conditions
s
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