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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01452451

Run by

Hanmi Pharmaceutical Company Limited

People needed

72

Starts

2011-12-01

Last updated by the study team

2016-08-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Study site — Ohio City, Ohio, United States

Full record on ClinicalTrials.gov

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