Study Stopped
Decision by Sponsor
Single Ascending Dose Trial in Patients With Type 2 Diabetes
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes
1 other identifier
interventional
47
1 country
3
Brief Summary
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus
Started Nov 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 15, 2013
February 1, 2013
8 months
September 28, 2011
February 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Subject incidence of treatment-emergent adverse events
Physical examinations, vitals, clinical laboratories, and ECGs
29 days
Safety laboratory analytes, vital signs, and ECGs
laboratory analytes, vital signs, and ECGs
29 days
Subject incidence of anti-AMG 876 antibodies.
laboratories analytes
29 days
Secondary Outcomes (2)
AMG 876 serum PK parameters
29 days
Pharmacodynamic parameters:
29 days
Study Arms (2)
AMG 876
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Ascending single doses of study drug administered SC, with one cohort administered IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (3)
Research Site
Omaha, Nebraska, 68154, United States
Research Site
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
December 15, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
February 15, 2013
Record last verified: 2013-02