Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 \<estimated glomerular filtration rate \<90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio \>30 mg/g.
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01452451
Start Date
December 1 2011
Last Update
August 9 2016
Active Locations (1)
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1
Ohio City, Ohio, United States