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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名: | UMIN ID: |
試験進捗状況 | 試験終了/Completed |
UMIN試験ID | UMIN000005129 |
受付番号 | R000006089 |
科学的試験名 | Continuous Glucose Monitoring System(CGMS)からみたBIAsp 30とBHI 30の食後血糖抑制効果の比較 |
一般公開日(本登録希望日) | 2011/02/23 |
最終更新日 | 2011/02/23 |
基本情報/Basic information | |||
一般向け試験名/Public title | Continuous Glucose Monitoring System(CGMS)からみたBIAsp 30とBHI 30の食後血糖抑制効果の比較 | Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30 | |
一般向け試験名略称/Acronym | Continuous Glucose Monitoring System(CGMS)からみたBIAsp 30とBHI 30の食後血糖抑制効果の比較 | Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30 | |
科学的試験名/Scientific Title | Continuous Glucose Monitoring System(CGMS)からみたBIAsp 30とBHI 30の食後血糖抑制効果の比較 | Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30 | |
科学的試験名略称/Scientific Title:Acronym | Continuous Glucose Monitoring System(CGMS)からみたBIAsp 30とBHI 30の食後血糖抑制効果の比較 | Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30 | |
試験実施地域/Region |
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対象疾患/Condition | |||
対象疾患名/Condition | 2型糖尿病 | type 2 diabetes | |
疾患区分1/Classification by specialty |
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疾患区分2/Classification by malignancy | 悪性腫瘍以外/Others | ||
ゲノム情報の取扱い/Genomic information | いいえ/NO |
目的/Objectives | ||
目的1/Narrative objectives1 | 2型糖尿病患者においてContinuous Glucose Monitoring System(CGMS)を用いて, BIAsp30とBHI30による食後血糖抑制効果を食後の平均皮下糖濃度と糖濃度変動指標により検討. | Biphasic insulin aspart 30 (BIAsp30) has an earlier and stronger peak effect with a similar duration of action to biphasic human insulin 30 (BHI30). However, direct comparison of daily glucose excursion during treatment with these two types of insulin has not been done. |
目的2/Basic objectives2 | 有効性/Efficacy | |
目的2 -その他詳細/Basic objectives -Others | ||
試験の性質1/Trial characteristics_1 | ||
試験の性質2/Trial characteristics_2 | ||
試験のフェーズ/Developmental phase |
評価/Assessment | ||
主要アウトカム評価項目/Primary outcomes | 連続72時間における糖濃度,糖濃度変動指標には mean amplitude of glucose excursion (MAGE),糖濃度の標準偏差(SD)を評価 | Assessment of CGM Parameters and Data Analysis
After downloading the recorded data, the following parameters were analyzed from the intermediate 48 hours of data: average glucose level (AG), standard deviation (SD) of glucose, mean amplitude of glucose excursion (MAGE), area under the glucose curve (AUC-glu) during the 30-min period before each meal, at 1-2 hour, 2-3 hour, and 3-4 hour after each meal, and during the night (10PM to 7AM), and area under the curve of incremental (baseline-corrected) postprandial glucose from just before to 4 hours after each meal (IAUC0-4h). |
副次アウトカム評価項目/Key secondary outcomes |
基本事項/Base | ||
試験の種類/Study type | 介入/Interventional |
試験デザイン/Study design | ||
基本デザイン/Basic design | クロスオーバー試験/Cross-over | |
ランダム化/Randomization | ランダム化/Randomized | |
ランダム化の単位/Randomization unit | ||
ブラインド化/Blinding | オープン/Open -no one is blinded | |
コントロール/Control | 実薬・標準治療対照/Active | |
層別化/Stratification | ||
動的割付/Dynamic allocation | ||
試験実施施設の考慮/Institution consideration | ||
ブロック化/Blocking | ||
割付コードを知る方法/Concealment |
介入/Intervention | |||
群数/No. of arms | 2 | ||
介入の目的/Purpose of intervention | 治療・ケア/Treatment | ||
介入の種類/Type of intervention |
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介入1/Interventions/Control_1 | BIAsp30⇒BHI30
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BIAsp30 to BHI30
After enrollment, patients were randomized to the BIAsp30 group or BHI30 group. Then, sulfonylurea therapy was suspended and insulin was started twice daily (before breakfast and dinner) at the outpatient clinic. BIAsp30 and BHI30 were injected just before meals and 30 min before meals, respectively. The insulin dosage was adjusted to achieve individual target levels, which were set by the attending physician considering each patients clinical condition. |
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介入2/Interventions/Control_2 | BHI30⇒ BIAsp30 | BHI30 to BIAsp30 | |
介入3/Interventions/Control_3 | |||
介入4/Interventions/Control_4 | |||
介入5/Interventions/Control_5 | |||
介入6/Interventions/Control_6 | |||
介入7/Interventions/Control_7 | |||
介入8/Interventions/Control_8 | |||
介入9/Interventions/Control_9 | |||
介入10/Interventions/Control_10 |
適格性/Eligibility | |||||
年齢(下限)/Age-lower limit |
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年齢(上限)/Age-upper limit |
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性別/Gender | 男女両方/Male and Female | ||||
選択基準/Key inclusion criteria | 2型糖尿病 | type2 DM
Inclusion criteria were stable but inadequate glycemic control (HbA1c>7.8% and variation of HbA1c by <0.5% within 3 months before enrollment) and treatment with a sulfonylurea only (not insulin with or without other oral antidiabetic agents). |
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除外基準/Key exclusion criteria | 妊娠、腎不全、慢性肝疾患、悪性疾患 | The exclusion criteria included pregnancy, severe medical illnesses, anemia, renal failure (serum creatinine>2.0 mg/dl), overt proteinuria, chronic liver disease, thyroid disease, malignancy, or severe hypoglycemia requiring assistance within the previous 6 months. | |||
目標参加者数/Target sample size | 12 |
責任研究者/Research contact person | ||||||||||||||
責任研究者/Name of lead principal investigator |
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所属組織/Organization | 聖マリアンナ医科大学 | St. Marianna University School of Medicine | ||||||||||||
所属部署/Division name | 代謝・内分泌内科 | Department of Internal Medicine, Division of Metabolism and Endocrinology | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 神奈川県川崎市宮前区菅生2-16-1 | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan | ||||||||||||
電話/TEL | ||||||||||||||
Email/Email |
試験問い合わせ窓口/Public contact | ||||||||||||||
試験問い合わせ窓口担当者/Name of contact person |
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組織名/Organization | 聖マリアンナ医科大学 | St. Marianna University School of Medicine | ||||||||||||
部署名/Division name | 代謝・内分泌内科 | Department of Internal Medicine, Division of Metabolism and Endocrinology | ||||||||||||
郵便番号/Zip code | ||||||||||||||
住所/Address | 神奈川県川崎市宮前区菅生2-16-1 | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan | ||||||||||||
電話/TEL | ||||||||||||||
試験のホームページURL/Homepage URL | ||||||||||||||
Email/Email |
実施責任組織/Sponsor | ||
機関名/Institute | その他 | St. Marianna University School of Medicine |
機関名/Institute (機関選択不可の場合) |
聖マリアンナ医科大学 | |
部署名/Department |
研究費提供組織/Funding Source | ||
機関名/Organization | その他 | No source |
機関名/Organization (機関選択不可の場合) |
なし | |
組織名/Division | ||
組織の区分/Category of Funding Organization | 自己調達/Self funding | |
研究費拠出国/Nationality of Funding Organization |
その他の関連組織/Other related organizations | ||
共同実施組織/Co-sponsor | ||
その他の研究費提供組織/Name of secondary funder(s) |
IRB等連絡先(公開)/IRB Contact (For public release) | ||
組織名/Organization | ||
住所/Address | ||
電話/Tel | ||
Email/Email |
他機関から発行された試験ID/Secondary IDs | ||
他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
試験ID1/Study ID_1 | ||
ID発行機関1/Org. issuing International ID_1 | ||
試験ID2/Study ID_2 | ||
ID発行機関2/Org. issuing International ID_2 | ||
治験届/IND to MHLW |
試験実施施設/Institutions | ||
試験実施施設名称/Institutions |
その他の管理情報/Other administrative information | ||||||||
一般公開日(本登録希望日)/Date of disclosure of the study information |
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関連情報/Related information | ||
プロトコル掲載URL/URL releasing protocol | ||
試験結果の公開状況/Publication of results | 未公表/Unpublished |
結果/Result | ||
結果掲載URL/URL related to results and publications | ||
組み入れ参加者数/Number of participants that the trial has enrolled | ||
主な結果/Results | ||
主な結果入力日/Results date posted | ||
結果掲載遅延/Results Delayed | ||
結果遅延理由/Results Delay Reason | ||
最初の試験結果の出版日/Date of the first journal publication of results | ||
参加者背景/Baseline Characteristics | ||
参加者の流れ/Participant flow | ||
有害事象/Adverse events | ||
評価項目/Outcome measures | ||
個別症例データ共有計画/Plan to share IPD | ||
個別症例データ共有計画の詳細/IPD sharing Plan description |
試験進捗状況/Progress | ||||||||
試験進捗状況/Recruitment status | 試験終了/Completed | |||||||
プロトコル確定日/Date of protocol fixation |
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倫理委員会による承認日/Date of IRB | ||||||||
登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date | ||||||||
入力終了(予定)日/Date of closure to data entry | ||||||||
データ固定(予定)日/Date trial data considered complete | ||||||||
解析終了(予定)日/Date analysis concluded |
その他/Other | ||
その他関連情報/Other related information |
管理情報/Management information | ||||||||
登録日時/Registered date |
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最終更新日/Last modified on |
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閲覧ページへのリンク/Link to view the page | |
URL(日本語) | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006089 |
URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006089 |
研究計画書 | |
登録日時 | ファイル名 |
研究症例データ仕様書 | |
登録日時 | ファイル名 |
研究症例データ | |
登録日時 | ファイル名 |