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Multiple Ascending Dose Study in Subjects 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: NCT01856881
Recruitment Status : Terminated (This study was terminated on August 29th, 2014 due to a business decision by the Sponsor. The study was not terminated due to a safety reason.)
First Posted : May 20, 2013
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2 diabetes.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AMG 876 Drug: AMG 876
Ascending multiple doses of study drug administered SC

Placebo Comparator: Placebo Drug: AMG 876
Ascending multiple doses of study drug administered SC




Primary Outcome Measures :
  1. Subject incidence of treatment-emergent adverse events [ Time Frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8). ]
    Physical examinations, vitals, laboratory analytes, and ECGs

  2. Subject incidence of anti-AMG 876 antibodies [ Time Frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8). ]
    Laboratory analytes


Secondary Outcome Measures :
  1. AMG 876 serum PK parameters [ Time Frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8). ]
    Concentration-time profiles for AMG 876

  2. Pharmacodynamic parameters [ Time Frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8). ]
    Concentration of fasting glucose, insulin, and C-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, C peptide, glucagon, and non-esterified fatty acid concentrations); Fasting lipid levels (total cholesterol, low-density lipoprotein [LDL], high-density lipoprotein [HDL], and triglycerides); The following 7-point SMBG parameters: pre-meal average blood glucose, post-meal average blood glucose, 7-point average blood glucose, post-meal excursion, post-meal excursion average; Body weight, 24 hour weighted mean glucose(cohort 9 only)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects ≥ 18 to ≤ 65 years of age at the time of randomization
  • Female subjects must be of documented non-reproductive potential
  • Diagnosed with type 2 diabetes
  • HbA1c ≥ 6.5% and ≤ 10%
  • Fasting C-peptide value ≥ 0.8 ng/mL
  • Body mass index (BMI) between ≥ 25.0 and ≤ 40.0 kg/m2 at screening

Exclusion Criteria:

  • Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 4 weeks after receiving the last dose of study drug.
  • Male subjects with partners who are pregnant or planning to become pregnant while the subject is on study through 4 weeks after receiving the last dose of study drug
  • Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, estimated glomerular filtration rate < 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 atrial or ventricular etiology, unexplained syncope, or syncope/seizures related to arrhythmia
  • Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening
  • Triglycerides ≥ 500 mg/dL (5.64 mmol/L) at screening
  • Hepatic liver enzymes ALT, AST, alkaline phosphatase (ALP), or total bilirubin (TBIL) levels > 1.5 times the upper limit of normal (ULN) at screening
  • Fasting blood glucose > 270 mg/dL at the screening visit
  • Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus antibodies (HepCAb)
  • 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)

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): NCT01856881


Locations
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United States, California
Research Site
Chula Vista, California, United States, 91911
United States, Florida
Research Site
Miramar, Florida, United States, 33025
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66212
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45255
United States, Texas
Research Site
San Antonio, Texas, United States, 78209
United States, Washington
Research Site
Renton, Washington, United States, 98057
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01856881    
Other Study ID Numbers: 20100018
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Keywords provided by Amgen:
Type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases