A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus
| City: |
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Brooksville |
| State: |
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Florida |
| Zip Code: |
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34601 |
| Conditions: |
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Diabetes Mellitus |
| Purpose: |
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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 at least 3 months prior to randomization.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 18 to 65 years, inclusive
- Diagnosis of type 2 diabetes mellitus
- HbA1c levels 7.5% to 10.0%, inclusive, at screening
- Fasting C-peptide levels ≥ 0.2 nmol/L at screening
- BMI ≥ 25 to < 40 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 Criteria:
- History of type 1 diabetes
- History of significant weight gain or loss (± 5%) 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 outpatient insulin at any time 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
- Known history of HIV, hepatitis B or hepatitis C
- 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 > 90 mm Hg or systolic
pressure > 150 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
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| NCT ID: |
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NCT01464437 |
| Primary Contact: |
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Study Director
MD
Amgen
Amgen Call Center
Phone: 866-572-6436
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| Backup Contact: |
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N/A |
| Location Contact: |
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Brooksville, Florida 34601
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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