Single Ascending Dose Trial in Patients With Type 2 Diabetes

This study has been terminated.
(Decision by Sponsor)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01492465
First received: September 28, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus
Drug: AMG 876
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of treatment-emergent adverse events [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    Physical examinations, vitals, clinical laboratories, and ECGs

  • Safety laboratory analytes, vital signs, and ECGs [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    laboratory analytes, vital signs, and ECGs

  • Subject incidence of anti-AMG 876 antibodies. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
    laboratories analytes


Secondary Outcome Measures:
  • AMG 876 serum PK parameters [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Concentration-time profiles for AMG 876

  • Pharmacodynamic parameters: [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Concentration of fasting glucose, insulin and c-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, c-peptide, glucagon and free fatty acid concentrations) following a mixed meal tolerance test; Lipid levels (ie, total cholesterol, LDL, HDL, and triglycerides); Body weight.


Enrollment: 47
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 876 Drug: AMG 876
Ascending single doses of study drug administered SC, with one cohort administered IV
Placebo Comparator: Placebo Drug: AMG 876
Ascending single doses of study drug administered SC, with one cohort administered IV

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492465

Locations
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68154
United States, Texas
San Antonio, Texas, United States, 78209
Research Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01492465     History of Changes
Other Study ID Numbers: 20100015
Study First Received: September 28, 2011
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014