Overview
Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hanmi Pharmaceutical Company LimitedTreatments:
Exenatide
Criteria
Inclusion Criteria:- Is male or female and 18 to 65 years of age, inclusive, at screening
- Has a history of T2DM and a stable dose of metformin
- Has HbA1c levels at screening between 7% and 10%
Exclusion Criteria:
- Is pregnant or lactating
- Has type 1 diabetes
- Has a significant change in body weight in the 3 months before screening
- Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
- Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75
mL/min/1.73 m2
- Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit
of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a
known history of Gilbert's syndrome
- Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L)
if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or
has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V
hyperlipidemia will be excluded.
- Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease,
partial bypass or gastric banding
- Has any acute illness within 5 days before first study drug administration
- Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history
of pancreatitis
- Is a heavy tobacco user(more than 10 cigarettes a day)
- Is a heavy alcohol user
- Has a positive screen for drugs of abuse