KCT0000614Recruiting未知
The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients with Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea
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
- •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)
Investigators
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