Clinical Trial Details
| Trial ID: | L7048 |
| Source ID: | NCT00995345 |
| Associated Drug: | Krp-104 |
| Title: | Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone |
| Acronym: | Synergy104 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00995345/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: KRP-104|DRUG: Placebo |
| Outcome Measures: | Primary: Change in HbA1c From Baseline (Week 0) to Week 24, Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE), Week 24 | Secondary: Change in Body Weight, Mean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT, 24 weeks|Percentage of Patients Achieving HbA1c Less Than 7%, Subjects Achieving Target of Hemoglobin A1c \<7.0% at Week 24 with LOCF - Intent-to-Treat Population, 24 weeks|Percentage of Patients Requiring Rescue Therapy for Elevated Glucose, Percentage of Subjects Requiring Rescue Therapy - Intent-to-Treat Population, 24 weeks of treatment. |
| Sponsor/Collaborators: | Sponsor: ActivX Biosciences, Inc. | Collaborators: Kyorin Pharmaceutical Co.,Ltd |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 403 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2009-10 |
| Completion Date: | 2011-01 |
| Results First Posted: | 2014-06-26 |
| Last Update Posted: | 2014-06-26 |
| Locations: | Birmingham, Alabama, United States|Phoenix, Arizona, United States|Los Angeles, California, United States|Valley Village, California, United States|Honolulu, Hawaii, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Delaware, Ohio, United States|Marion, Ohio, United States|Beaver, Pennsylvania, United States|Jenkintown, Pennsylvania, United States|Greer, South Carolina, United States|Austin, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Sandy, Utah, United States|West Jordan, Utah, United States|Ciudad Autonoma de Buenos Aires, Argentina|Cordoba, Argentina|Loma Hermos Buenos Aires, Argentina|Chrudim III, Czech Republic|Holesov, Czech Republic|Melnik, Czech Republic|Ostrava, Czech Republic|Praha 10, Czech Republic|Praha 8, Czech Republic|Guatemala City, Guatemala|Bialystok, Poland|Gdansk, Poland|Krakow, Poland|Lodz, Poland|Warszawa, Poland|Wroclaw, Poland|Arkhangel'sk, Russian Federation|Kemerovo, Russian Federation|Moscow, Russian Federation|Novosibirsk, Russian Federation|St. Petersburg, Russian Federation|Port Elizabeth, Eastern Cape, South Africa|Bloemfontein, Free State, South Africa|Johannesburg, Gauteng, South Africa|Soweto, Gauteng, South Africa|Durban, Kwazula-Natal, South Africa|Cape Town, Western Cape, South Africa|Paarl, Western Cape, South Africa|Somerset West, Western Cape, South Africa |
| URL: | https://clinicaltrials.gov/show/NCT00995345 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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