A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

Not Applicable

Recruiting

Conditions: Endocrine, nutritional and metabolic disease

Registration Number: KCT0000614

Lead Sponsor: Eli Lilly Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 789

Inclusion Criteria

Have type 2 diabetes mellitus for at least 6 months
-Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
-HbA1c value of =7.0% to =11.0%
-Adult men or adult non-pregnant, non-breastfeeding women
-Body Mass Index (BMI) of =19.0 to =35.0 kilograms/square meter (kg/m^2)
-Stable weight (±5%) =3 months prior to screening

Exclusion Criteria

-Have type 1 diabetes mellitus
-Have previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
-Have treatment with dipeptidylpeptidase-IV(DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
-Have gastric emptying abnormality
-Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
-Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)
-Impaired liver function
-Impaired kidney function
-Have history of chronic pancreatitis or acute pancreatitis
-Have a serum calcitonin =20 picogram/milliliter (pg/mL)
-Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks;Percentage of Participants Attaining HbA1c of <7% or =6.5% at 26 Weeks and 52 Weeks;Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks;Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (ß)- cell function (HOMA2-%B) at 26 Weeks and 52 Weeks;Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (ß)- cell function (HOMA2-%B) at 26 Weeks and 52 Weeks;Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks and 52 Weeks;Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks and 52 Weeks