Status:
COMPLETED
AMG 151 Amgen Protocol Number 20100761
Lead Sponsor:
Amgen
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for a...
Eligibility Criteria
Inclusion
- Age 18 to 75 years, inclusive
- Diagnosis of type 2 diabetes mellitus
- HbA1c levels 7.5% to 11.0%, inclusive, at screening
- Fasting C-peptide levels ≥ 0.2 nmol/L at screening
- BMI ≥ 25 to \< 45 kg/m2 at screening
- Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
- If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
- Subject has provided informed consent.
Exclusion
- History of type 1 diabetes
- History of significant weight gain or loss (\> 10%) during the 4 weeks before randomization
- Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
- Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
- Use of chronic and/or continuous insulin administration for \> 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
- Evidence of active infections that can interfere with the study
- Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
- Currently receiving immunosuppressive therapy
- History of positive HIV, chronic hepatitis B or C, or cirrhosis
- Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
- Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
- Poorly controlled hypertension defined as diastolic pressure \> 100 mm Hg or systolic pressure \> 160 mm Hg (assessed on two separate occasions during the screening period)
- Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred \> 5 years ago, subject is eligible with documentation of disease-free state since treatment)
- Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01464437
Start Date
September 1 2011
End Date
December 1 2012
Last Update
May 13 2014
Active Locations (77)
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1
Research Site
Birmingham, Alabama, United States, 35216
2
Research Site
Phoenix, Arizona, United States, 85021
3
Research Site
Tucson, Arizona, United States, 85704
4
Research Site
Little Rock, Arkansas, United States, 72205