AMG 151 Amgen Protocol Number 20100761
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes Mellitus |
| Intervention | Drug: AMG 151 Drug: Placebo Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | Amgen |
| Responsible Party | Amgen |
| ClinicalTrials.gov Identifier | NCT01464437 |
| First Received | October 14, 2011 |
| Last Updated | March 14, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 14, 2011 |
|---|---|
| Last Updated Date | March 14, 2014 |
| Start Date | September 2011 |
| Estimated Primary Completion Date | December 2012 |
| Current Primary Outcome Measures | To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin [Time Frame: Change in fasting plasma glucose levels from baseline to Day 28] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | AMG 151 Amgen Protocol Number 20100761 |
|---|---|
| Official Title | 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 |
| 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 at least 3 months prior to randomization. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus |
| Intervention | Drug: AMG 151 AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization. Eligible subjects will be randomly assigned in a 1:1:1:1:1:1:1 ratio to receive AMG 151 at different doses or placebo for 28 days. Drug: Placebo Placebo Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 236 |
| Estimated Completion Date | December 2012 |
| Estimated Primary Completion Date | October 2012 |
| Eligibility Criteria | Inclusion Criteria: - 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 Criteria: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Czech Republic, Estonia, Poland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01464437 |
|---|---|
| Other Study ID Numbers | 20100761 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Amgen |
| Study Sponsor | Amgen |
| Collaborators | Not Provided |
| Investigators | Study Director: MD Amgen |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Research Site | Birmingham, Alabama, United States, 35216 |
|---|---|
| Research Site | Phoenix, Arizona, United States, 85021 |
| Research Site | Tucson, Arizona, United States, 85704 |
| Research Site | Little Rock, Arkansas, United States, 72205 |
| Research Site | Anaheim, California, United States, 92801 |
| Research Site | Chula Vista, California, United States, 91911 |
| Research Site | Fresno, California, United States, 93720 |
| Research Site | Greenbrae, California, United States, 94904 |
| Research Site | Inglewood, California, United States, 90301 |
| Research Site | Lomita, California, United States, 90717 |
| Research Site | Los Angeles, California, United States, 90017 |
| Research Site | Los Angeles, California, United States, 90057 |
| Research Site | Palm Desert, California, United States, 92260 |
| Research Site | Roseville, California, United States, 95661 |
| Research Site | San Diego, California, United States, 92161 |
| Research Site | San Jose, California, United States, 95123 |
| Research Site | Walnut Creek, California, United States, 94598 |
| Research Site | Watsonville, California, United States, 95076 |
| Research Site | Bradenton, Florida, United States, 34208 |
| Research Site | Brooksville, Florida, United States, 34601 |
| Research Site | Clearwater, Florida, United States, 33756 |
| Research Site | Fort Myers, Florida, United States, 33912 |
| Research Site | Kissimmee, Florida, United States, 34741 |
| Research Site | Maitland, Florida, United States, 32751 |
| Research Site | Palm Harbor, Florida, United States, 34684 |
| Research Site | Saint Petersburg, Florida, United States, 33716 |
| Research Site | St. Petersburg, Florida, United States, 33709 |
| Research Site | Tampa, Florida, United States, 33606 |
| Research Site | Winter Park, Florida, United States, 32789 |
| Research Site | Atlanta, Georgia, United States, 30338 |
| Research Site | Columbus, Georgia, United States, 31904 |
| Research Site | Dunwoody, Georgia, United States, 30338 |
| Research Site | Roswell, Georgia, United States, 30076 |
| Research Site | Meridian, Idaho, United States, 83642 |
| Research Site | Chigago, Illinois, United States, 60607 |
| Research Site | Indianapolis, Indiana, United States, 46202 |
| Research Site | Metairie, Louisiana, United States, 70006 |
| Research Site | Bethesda, Maryland, United States, 20817 |
| Research Site | St. Louis, Missouri, United States, 63128 |
| Research Site | Bozeman, Montana, United States, 59718 |
| Research Site | Las Vegas, Nevada, United States, 89117 |
| Research Site | Las Vegas, Nevada, United States, 89106 |
| Research Site | Mineola, New York, United States, 11501 |
| Research Site | Raleigh, North Carolina, United States, 27612 |
| Research Site | Shelby, North Carolina, United States, 28150 |
| Research Site | Bismarck, North Dakota, United States, 58503 |
| Research Site | Fargo, North Dakota, United States, 58103 |
| Research Site | Cincinnati, Ohio, United States, 45227 |
| Research Site | Cleveland, Ohio, United States, 44122 |
| Research Site | Dayton, Ohio, United States, 45439 |
| Research Site | Kettering, Ohio, United States, 45429 |
| Research Site | Norman, Oklahoma, United States, 73069 |
| Research Site | Oklahoma City, Oklahoma, United States, 73112 |
| Research Site | Rapid City, South Dakota, United States, 57702 |
| Research Site | Dallas, Texas, United States, 75247 |
| Research Site | Dallas, Texas, United States, 75235 |
| Research Site | Houston, Texas, United States, 77074 |
| Research Site | Houston, Texas, United States, 77029 |
| Research Site | San Antonio, Texas, United States, 78229 |
| Research Site | Draper, Utah, United States, 84020 |
| Research Site | Salt Lake City, Utah, United States, 84124 |
| Research Site | Midlothian, Virginia, United States, 23114 |
| Research Site | Norfolk, Virginia, United States, 23510 |
| Research Site | Richmond, Virginia, United States, 23219 |
| Research Site | Salem, Virginia, United States, 24153 |
| Research Site | Brno, Czech Republic, 602 00 |
| Research Site | Pardubice, Czech Republic, 530 02 |
| Research Site | Praha 3, Czech Republic, 130 00 |
| Research Site | Tallinn, Estonia, 10128 |
| Research Site | Lodz, Poland, 90-368 |
| Research Site | Warszawa, Poland, 04-730 |
| Research Site | Carolina, Puerto Rico, 00983 |
| Research Site | Cidra, Puerto Rico, 00739 |
| Research Site | San Juan, Puerto Rico, 00909 |
| Research Site | San Juan, Puerto Rico, 00917 |
| Research Site | San Juan, Puerto Rico, 00926-2832 |
| Research Site | San Juan, Puerto Rico, 00920 |