Efficacy and Safety study of LY3298176 versus Insulin Glargine in Patients with Type 2 Diabetes and Increased Cardiovascular Risk

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2002

Inclusion Criteria

[1] Have been diagnosed with T2DM
[2] Have HbA1c between =7.5% (58 mmol/mol) and =10.5% (91 mmol/mol) at screening
[3] On stable treatment with unchanged dose of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 3 months before screening
[4] Increased risk of CV events as defined by at least 1 of the following (a – e):
a) Coronary heart disease
OR
b) Peripheral arterial disease
OR
c) Cerebrovascular disease
OR
d) Age =50 years, history of CKD, and an estimated glomerular filtration rate <60 mL/min/1.73m2 (CKD-Epidemiology[CKD-EPI]) on consecutive
measurements
OR
e) Age =50 years and congestive heart failure (CHF)
[5] Are of stable weight (± 5%) =3 months prior to screening
[6] Have a BMI =25 kg/m2 at screening
[7] Eighteen years or older at the time of signing informed consent
Male patients:
Male patients should be willing to use reliable contraceptive methods throughout the study and for at least 3 months after last injection
Female patients:
Female patients not of childbearing potential due to surgical sterilization
(hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause.
Female patients of childbearing potential (not surgically sterilized and
between menarche and 1-year postmenopausal) must
•?test negative for pregnancy at Visit 1 based on a serum pregnancy
test
AND
•?if sexually active, agree to use 2 forms of effective contraception,
where at least 1 form is highly effective for the duration of the trial
and for 30 days thereafter
•?not be breastfeeding
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 1409
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 469

Exclusion Criteria

[10] Have type 1 diabetes mellitus
[11] Had chronic or acute pancreatitis
[12] Have a history of proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy that requires acute treatment
[13] Have a history of ketoacidosis or hyperosmolar state/coma
[14] Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 6 months prior to screening
[15] Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
or chronically take drugs that directly affect GI motility
[16] New York Heart Association Functional Classification IV congestive heart failure
[17] Have any of the following CV conditions within 2 months prior to screening:
acute myocardial infarction, cerebrovascular accident (stroke), or
hospitalization for CHF
[18] Have acute or chronic hepatitis, signs or symptoms of any other liver disease,
[19] Have evidence of a significant, uncontrolled endocrine abnormality
[20] Have family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
[21] Have a raised serum calcitonin level
[22] Have evidence of significant, active autoimmune abnormality
[25] Have had a transplanted organ or awaiting an organ transplant
[26] Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than
5 years
[29] Have a history of insulin therapy except for the use of insulin for treatment of gestational diabetes or acute, temporary use of insulin (=14 days)
[30] Treatment with any glucose-lowering agent(s) other than stated in the
inclusion criteria (including DPP-4 inhibitors and GLP-1 receptor agonists) in a period of 3 months before screening prior to screening
[31] Are receiving chronic (>2 weeks or 14 days) systemic glucocorticoid therapy or have received such therapy within 1 month of screening
[32] Have been treated with drugs that promote weight loss within 3 months prior to screening and/or between screening and randomization

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

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