KCT0000576Recruiting未知
The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
Eli Lilly Korea0 sites789 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 789
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 18(Year) to o Limit (—)
- Sex
- All
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)
Investigators
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