Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Hanmi Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus

Treatments

Drug: Placebo

Drug: HM11260C

Study type

Interventional

Funder types

Industry

Identifiers

NCT01452451

HM-EXC-202

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 <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