Status:
TERMINATED
Multiple Ascending Dose Study in Subjects With Type 2 Diabetes
Lead Sponsor:
Amgen
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion
- Male and female subjects ≥ 18 to ≤ 65 years of age at the time of randomization
- Female subjects must be of documented non-reproductive potential
- Diagnosed with type 2 diabetes
- HbA1c ≥ 6.5% and ≤ 10%
- Fasting C-peptide value ≥ 0.8 ng/mL
- Body mass index (BMI) between ≥ 25.0 and ≤ 40.0 kg/m2 at screening
Exclusion
- Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 4 weeks after receiving the last dose of study drug.
- Male subjects with partners who are pregnant or planning to become pregnant while the subject is on study through 4 weeks after receiving the last dose of study drug
- Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, estimated glomerular filtration rate \< 60 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula) or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness
- Significant cardiac disease, including but not limited to, evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of atrial or ventricular etiology, unexplained syncope, or syncope/seizures related to arrhythmia
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening
- Triglycerides ≥ 500 mg/dL (5.64 mmol/L) at screening
- Hepatic liver enzymes ALT, AST, alkaline phosphatase (ALP), or total bilirubin (TBIL) levels \> 1.5 times the upper limit of normal (ULN) at screening
- Fasting blood glucose \> 270 mg/dL at the screening visit
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus antibodies (HepCAb)
- An unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator (eg, risk of complications or adverse events unrelated to study participation)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01856881
Start Date
March 1 2013
End Date
March 1 2015
Last Update
November 6 2015
Active Locations (6)
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1
Research Site
Chula Vista, California, United States, 91911
2
Research Site
Miramar, Florida, United States, 33025
3
Research Site
Overland Park, Kansas, United States, 66212
4
Research Site
Cincinnati, Ohio, United States, 45255