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Clinical Trial Details

Trial ID: L5957
Source ID: NCT01276106
Associated Drug: Ac-201, 25mg
Title: Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01276106/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: AC-201, 25mg|DRUG: AC-201, 50mg|DRUG: AC-201, 75mg|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c From Baseline, For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\<0.05., 24 weeks |
Sponsor/Collaborators: Sponsor: TWi Biotechnology, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 259
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-01
Completion Date: 2012-03
Results First Posted: 2014-11-18
Last Update Posted: 2018-05-22
Locations: Catalina Research Institute, LLC, Chino, California, United States|National Research Institute, Los Angeles, California, United States|Clinical Research of South Florida, Coral Gables, Florida, United States|Jacksonville Impotence Treatment Center, Jacksonville, Florida, United States|Chicago Clinical Research Institute, Inc., Chicago, Illinois, United States|Clinical Investigation Specialists, Inc., Gurnee, Illinois, United States|Midwest Institute for Clinical Research, Inc., Indianapolis, Indiana, United States|L-MARC Research Center, Louisville, Kentucky, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, United States|Sterling Research Group, Ltd, Cincinnati, Ohio, United States|PriMed Clinical Research, Kettering, Ohio, United States|National Clinical Research-Richmond, Inc., Richmond, Virginia, United States|Rainier Clinical Research Center, Inc., Renton, Washington, United States|Changhua Christian Hospital, Changhua, Taiwan|Cheng Ching General Hospital, Taichung, Taiwan|Chung Shan Medical University Hospital, Taichung, Taiwan|Kuang Tien General Hospital, Taichung, Taiwan|Cardinal Tien Hospital, Taipei, Taiwan|Taipei Medical University Hospital, Taipei, Taiwan|Taipei Medical University-Shuang Ho Hospital, Taipei, Taiwan|Tri-Service General Hospital, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT01276106

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