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

Not Applicable

Recruiting

Conditions: Endocrine, nutritional and metabolic disease

Registration Number: KCT0000576

Lead Sponsor: Eli Lilly Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 789

Inclusion Criteria

1.Type 2 diabetes mellitus
2.OAM-naive or have been taking OAM monotherapy for at least 3 months
3.Glycosylated Hemoglobin (HbA1c) value of =7.0% to =10.5% for OAM-naive participant or =6.5% to =10.0% for participant taking OAM monotherapy
4.Adult men or adult non-pregnant, non-breastfeeding women
5.Stable weight (±5%) =3 months prior to screening
6.Body Mass Index (BMI) of =19.0 to =35.0 kilograms/square meter (kg/m^2)

Exclusion Criteria

1.Have type 1 diabetes mellitus
2.Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
3.Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
4.Have gastric emptying abnormality
5.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
6.Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury [mmHg] or diastolic blood pressure above 95 mmHg)
7.Impaired liver function
8.Impaired kidney function
9.Have history of chronic pancreatitis or acute pancreatitis
10.Have a serum calcitonin =20 picogram/milliliter (pg/mL)
11.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
Percentage of Participants Attaining HbA1c of<7% or =6.5% at 26 Weeks;Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks;Change from Baseline in 7-point self-monitored blood glucose (SMBG) profiles at 26 Weeks;Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (ß) - cell function (HOMA2-%B) at 26 Weeks;Change from Baseline in Homeostasis Model Assessment 2 insulin sensitivity - cell function (HOMA2-%S) at 26 Weeks