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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00661921 |
The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG 108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c from baseline to end of treatment (EOT).
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus |
Biological: AMG 108 Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Mutiple Dose, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous AMG 108 in Patients With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 200 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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40 mg AMG 108 Q2W: Active Comparator |
Biological: AMG 108
IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
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150 mg AMG 108 Q2W: Active Comparator |
Biological: AMG 108
IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
|
75 mg AMG 108 Q2W: Active Comparator |
Biological: AMG 108
IL-1 inhibitor, subcutaneous injection given every 2 weeks for the duration of the trial. Doses include 150 mg, 75mg, and 40 mg.
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Placebo Q2W: Placebo Comparator |
Biological: Placebo
AMG 108 volume matching placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20070212 |
Study First Received: | April 17, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00661921 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Type 2 Diabetes Mellitus AMG 108 HbA1C glucose metformin |
sulfonylurea IL-1 Inhibitor biologic subcutaneous injection |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |