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Single Ascending Dose Trial in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01492465
Recruitment Status : Terminated (Decision by Sponsor)
First Posted : December 15, 2011
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: AMG 876 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Primary Completion Date : July 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Subject incidence of treatment-emergent adverse events [ Time Frame: 29 days ]
    Physical examinations, vitals, clinical laboratories, and ECGs

  2. Safety laboratory analytes, vital signs, and ECGs [ Time Frame: 29 days ]
    laboratory analytes, vital signs, and ECGs

  3. Subject incidence of anti-AMG 876 antibodies. [ Time Frame: 29 days ]
    laboratories analytes


Secondary Outcome Measures :
  1. AMG 876 serum PK parameters [ Time Frame: 29 days ]
    Concentration-time profiles for AMG 876

  2. Pharmacodynamic parameters: [ Time Frame: 29 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492465


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01492465     History of Changes
Other Study ID Numbers: 20100015
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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