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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00733577 |
This is an escalating dose study in subjects with T2DM, which will consist of four overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: SB756050 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety Study |
Official Title: | A Single-Blinded Randomized, Placebo-Controlled, Staggered-Parallel, Escalating-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral SB756050 Administered for 6 Days to Subjects With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 48 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, California | |
GSK Investigational Site | Withdrawn |
Chula Vista, California, United States, 91910 | |
United States, Florida | |
GSK Investigational Site | Recruiting |
Orlando, Florida, United States, 32809 | |
GSK Investigational Site | Recruiting |
Miami, Florida, United States, 33169 | |
United States, Maryland | |
GSK Investigational Site | Withdrawn |
Baltimore, Maryland, United States, 21225 | |
United States, New Jersey | |
GSK Investigational Site | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
United States, Texas | |
GSK Investigational Site | Recruiting |
San Antonio, Texas, United States, 78209 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111829 |
Study First Received: | August 12, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00733577 |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
diabetes pharmacokinetics pharmacodynamics safety |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |