Status:
TERMINATED
Single Ascending Dose Trial in Patients 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 determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
Eligibility Criteria
Inclusion
- Subject has provided written informed consent
- Men and women between the ages of 18 and 65, inclusive at the time of randomization
- Women must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- Diagnosed with type 2 diabetes
- HbA1c ≥ 6.5% and ≤ 10%
- Fasting C-peptide value ≥ 0.8 ng/mL
- Men must agree for the duration of the study and continuing for 4 weeks after the dose of study drug, to practice a highly effective method of birth control. Highly effective methods of birth control include sexual abstinence, vasectomy or a condom with spermicide (men) in combination with either barrier methods, hormonal birth control or IUD (women).
- Men must agree to not donate sperm for the duration of the study and continuing for 4 weeks after the dose of study drug.
- Body mass index between ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 at screening
- Negative screening test for alcohol and potential drugs of abuse at screening and day -2, unless medication is prescribed by a physician and approved by the principal investigator and Amgen medical monitor
Exclusion
- Men with partners who are pregnant at the time of screening or men with partners who plan to become pregnant during the study
- Women who are pregnant or breastfeeding History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance \< 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 ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (Hbs Ag), or hepatitis C virus antibodies
- 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 :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01492465
Start Date
November 1 2011
End Date
October 1 2012
Last Update
February 15 2013
Active Locations (3)
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1
Research Site
Omaha, Nebraska, United States, 68154
2
Research Site
San Antonio, Texas, United States, 78209
3
San Antonio, Texas, United States, 78209