Clinical trial NCT01492465: Single Ascending Dose Trial in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Type 2 diabetes
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Subject incidence of treatment-emergent adverse events
timeFrame: 29 days
measure: Safety laboratory analytes, vital signs, and ECGs
timeFrame: 29 days
measure: Subject incidence of anti-AMG 876 antibodies.
timeFrame: 29 days
Secondary outcomes:
measure: AMG 876 serum PK parameters
timeFrame: 29 days
measure: Pharmacodynamic parameters:
timeFrame: 29 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: