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【求助】AC2993一期、二期臨床研究申報(bào)資料
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| 跪求AC2993一期和二期臨床研究的申報(bào)資料，現(xiàn)要翻譯臨床研究有關(guān)增大劑量的副反應(yīng)、耐受性、安全性等的相關(guān)資料，可惜沒(méi)有電子版，本人英文能力有限，翻譯起來(lái)比較困難，最好有中文版的，不勝感激！ |
回復(fù)此樓» 收錄本帖的淘帖專(zhuān)輯推薦
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★ ★ ★ ★ ★
kidant(金幣+5):謝謝回帖交流 2010-11-03 09:10:28
嘉笛(金幣+5): 2010-11-24 10:42:17
kidant(金幣+5):謝謝回帖交流 2010-11-03 09:10:28
嘉笛(金幣+5): 2010-11-24 10:42:17
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Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination This study has been completed. First Received: September 3, 2002 Last Updated: November 5, 2007 History of Changes Sponsor: Amylin Pharmaceuticals, Inc. Collaborator: Eli Lilly and Company Information provided by: Amylin Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT00044668 Purpose This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination. Condition Intervention Phase Diabetes Mellitus, Type 2 Drug: AC2993 (synthetic exendin-4) Phase III Study Type: Interventional Study Design: Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination Resource links provided by NLM: MedlinePlus related topics: Diabetes Drug Information available for: Exenatide Metformin Metformin hydrochloride U.S. FDA Resources Further study details as provided by Amylin Pharmaceuticals, Inc.: Primary Outcome Measures: •*Examine long-term effect on glucose control of subcutaneously (SC) injected AC2993 administered twice a day (BID) in subjects with type 2 diabetes (T2DM);*Assess long-term safety of SC injected AC2993 administered BID in subjects with T2DM Secondary Outcome Measures: •*Examine long-term effect on various pharmacodynamic measurements of SC injected AC2993 administered BID in subjects with T2DM. Estimated Enrollment: 150 Study Start Date: August 2002 Eligibility Ages Eligible for Study: 20 Years to 75 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: •Subjects with type 2 diabetes •Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination •BMI 25-45 kg/m^2 •HbA1c between 7.5 % and 12.0 %, inclusive Exclusion Criteria: •Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening •Patients previously treated with AC2993 •Patients presently treated with insulin Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00044668 Locations Hungary Peterfy Teaching Hospital Budapest, Hungary, H 1076 Diagnostic Units Hungary Kft. Budapest, Hungary, H 1036 Uzsoki Street Municipal Hospital Budapest, Hungary, H 1145 Sponsors and Collaborators Amylin Pharmaceuticals, Inc. Eli Lilly and Company Investigators Study Director: Lisa Porter, MD Amylin Pharmaceuticals, Inc. More Information Additional Information: Link to study results on ClinicalStudyResults.org No publications provided ClinicalTrials.gov Identifier: NCT00044668 History of Changes Other Study ID Numbers: 2993-117 Study First Received: September 3, 2002 Last Updated: November 5, 2007 Health Authority: United States: Food and Drug Administration; Hungary: National Institute of Pharmacy Keywords provided by Amylin Pharmaceuticals, Inc.: exenatide exendin-4 diabetes Amylin Lilly Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
2樓2010-11-01 14:25:42
★ ★ ★ ★ ★
caoyuan521(金幣+2):謝謝授人以漁！ 2010-11-01 21:19:14
kidant(金幣+3):謝謝回帖交流 2010-11-03 09:10:37
caoyuan521(金幣+2):謝謝授人以漁！ 2010-11-01 21:19:14
kidant(金幣+3):謝謝回帖交流 2010-11-03 09:10:37
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http://clinicaltrials.gov/ct2/results?term=AC2993 樓主看下這個(gè)帖子吧，英語(yǔ)還是自己翻譯吧，可以鍛煉一下水平，翻譯兩三次你就都熟悉了！ 希望對(duì)你有幫助！ |
3樓2010-11-01 14:27:05
quchun12
銅蟲(chóng) (初入文壇)
- 應(yīng)助: 0 (幼兒園)
- 金幣: 261.5
- 帖子: 30
- 在線: 27.9小時(shí)
- 蟲(chóng)號(hào): 1114445
- 注冊(cè): 2010-10-05
- 專(zhuān)業(yè): 免疫相關(guān)疾病其他科學(xué)問(wèn)題
呢�。� 
4樓2010-11-03 08:44:24
deeplin
鐵蟲(chóng) (初入文壇)
- 應(yīng)助: 0 (幼兒園)
- 金幣: 86.8
- 帖子: 32
- 在線: 3.2小時(shí)
- 蟲(chóng)號(hào): 561747
- 注冊(cè): 2008-05-22
- 專(zhuān)業(yè): 中藥藥效物質(zhì)
5樓2010-11-03 09:00:41
xiefl1984 
木蟲(chóng) (小有名氣)
- 應(yīng)助: 31 (小學(xué)生)
- 金幣: 2465.1
- 帖子: 129
- 在線: 26.2小時(shí)
- 蟲(chóng)號(hào): 528140
- 注冊(cè): 2008-03-18
- 專(zhuān)業(yè): 生物大分子結(jié)構(gòu)與功能
★ ★ ★
koria0727(金幣+3):多謝提供。 2010-11-24 10:41:02
嘉笛(金幣+45):謝謝 2010-11-28 10:41:30
koria0727(金幣+3):多謝提供。 2010-11-24 10:41:02
嘉笛(金幣+45):謝謝 2010-11-28 10:41:30
6樓2010-11-24 10:39:02
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