Single Ascending Dose Trial in Patients With Type 2 Diabetes

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01492465
• Other study ID #: 20100015
• Status: Terminated
• Phase: Phase 1
• First received: September 28, 2011
• Last updated: February 13, 2013
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• AMG 876
Ascending single doses of study drug administered SC, with one cohort administered IV

Locations

Country	Name	City	State
United States	Research Site	Omaha	Nebraska
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of treatment-emergent adverse events	Physical examinations, vitals, clinical laboratories, and ECGs	29 days	Yes
Primary	Safety laboratory analytes, vital signs, and ECGs	laboratory analytes, vital signs, and ECGs	29 days	Yes
Primary	Subject incidence of anti-AMG 876 antibodies.	laboratories analytes	29 days	Yes
Secondary	AMG 876 serum PK parameters	Concentration-time profiles for AMG 876	29 days	No
Secondary	Pharmacodynamic parameters:	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.	29 days	No

External Links

•   AmgenTrials clinical trials website