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Terminated/Withdrawn
Sponsor ID
20100018

Multiple Ascending Dose Study in Subjects with Type 2 Diabetes

Sponsor ID
20100018
Clinicaltrials.gov ID
NCT01856881
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 876
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
86
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment-emergent adverse events

Timeframe: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).

Subject incidence of anti-AMG 876 antibodies

Timeframe: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).

Secondary Outcome Measures

AMG 876 serum PK parameters

Timeframe: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).

Pharmacodynamic parameters

Timeframe: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Chula Vista, CA, United States, 91911
Status
Completed
Location
Research Site
Overland Park, KS, United States, 66212
Status
Completed
Location
Research Site
Miramar, FL, United States, 33025
Status
Completed
Location
Research Site
San Antonio, TX, United States, 78209
Status
Completed
Location
Research Site
Renton, WA, United States, 98057
Status
Completed
Location
Research Site
Cincinnati, OH, United States, 45255
Status
Completed
Study Info
Age
18 - 65 Years
Condition
  • Diabetes
    • Sex
    All
    Trial Dates
    Mar 2013 - Nov 2014
    Inclusion and Exclusion 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)