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治験 NCT01326026 (BEGIN™)（対象：糖尿病、2型糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ノボノルディスクComparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™) 第III相・フェーズ3 222
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01326026 (BEGIN™) は 治療 の研究で、糖尿病、2型糖尿病 を対象とした 第III相・フェーズ3 介入研究 臨床試験 でした。現在は 完了 です。2011年3月1日 に開始し、222 名の参加者 が参加しました。この試験は ノボノルディスク によって主導され、2011年12月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2017年3月6日 です。
概要
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
公式タイトル
A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE)
疾患名
糖尿病2型糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- BEGIN™
- NN1250-3846
- U1111-1117-0616 (その他の識別子) (WHO)
- 2010-022337-29 (EudraCT番号)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的IDeg Simple | insulin degludec Injected subcutaneously (under the skin) once daily. Dose individually adjusted. |
実験的IDeg Step wise | insulin degludec Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 26 weeks of treatment. | Week 0, Week 26 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment. | Week 0, Week 26 |
Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. | Week 0 to Week 26 + 7 days follow up |
Rate of Confirmed Hypoglycaemic Episodes | Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | Week 0 to Week 26 + 7 days follow up |
Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. | Week 0 to Week 26 + 7 days follow up |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
- Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) no higher than 45.0 kg/m^2
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
- Suffer from a life threatening disease (e.g. cancer)
- Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise \[for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner\])
ノボノルディスク131 件のアクティブな治験を探索連絡先情報がありません。
45 4カ国の場所
Alabama
Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States
Novo Nordisk Investigational Site, Huntsville, Alabama, 35801, United States
California
Novo Nordisk Investigational Site, Anaheim, California, 92801, United States
Novo Nordisk Investigational Site, La Jolla, California, 92037, United States
Novo Nordisk Investigational Site, Mission Hills, California, 91345, United States
Novo Nordisk Investigational Site, National City, California, 91950, United States
Novo Nordisk Investigational Site, North Hollywood, California, 91606, United States
Novo Nordisk Investigational Site, San Diego, California, 92111, United States
Colorado
Novo Nordisk Investigational Site, Golden, Colorado, 80401, United States
Florida
Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States
Novo Nordisk Investigational Site, Tampa, Florida, 33603, United States
Georgia
Novo Nordisk Investigational Site, Columbus, Georgia, 31909, United States
Illinois
Novo Nordisk Investigational Site, Springfield, Illinois, 62711, United States
Indiana
Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States
Louisiana
Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States
Montana
Novo Nordisk Investigational Site, Billings, Montana, 59102, United States
New York
Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States
North Carolina
Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States
Ohio
Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States
Pennsylvania
Novo Nordisk Investigational Site, Melrose Park, Pennsylvania, 19027, United States
Rhode Island
Novo Nordisk Investigational Site, East Providence, Rhode Island, 02914, United States
Tennessee
Novo Nordisk Investigational Site, Humboldt, Tennessee, 38343, United States
Texas
Novo Nordisk Investigational Site, Houston, Texas, 77095, United States
Novo Nordisk Investigational Site, Killeen, Texas, 76543-5600, United States
Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States
Utah
Novo Nordisk Investigational Site, Ogden, Utah, 84403, United States
Novo Nordisk Investigational Site, St. George, Utah, 84790, United States
Novo Nordisk Investigational Site, Helsinki, 00260, Finland
Novo Nordisk Investigational Site, Kerava, FI-04200, Finland
Novo Nordisk Investigational Site, Tampere, 33210, Finland
Novo Nordisk Investigational Site, Turku, 20520, Finland
Novo Nordisk Investigational Site, Turku, FI-20100, Finland
Novo Nordisk Investigational Site, Berlin, 12163, Germany
Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany
Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany
Novo Nordisk Investigational Site, Münster, 48145, Germany
Novo Nordisk Investigational Site, Neuwied, 56564, Germany
Novo Nordisk Investigational Site, Völklingen, 66333, Germany
Novo Nordisk Investigational Site, Almería, 04001, Spain
Novo Nordisk Investigational Site, Antequera, 29200, Spain
Novo Nordisk Investigational Site, Gijón, 33206, Spain
Novo Nordisk Investigational Site, Málaga, 29006, Spain
Novo Nordisk Investigational Site, Palma de Mallorca, 07014, Spain
Novo Nordisk Investigational Site, Palma de Mallorca, 07198, Spain
Novo Nordisk Investigational Site, Pozuelo de Alarcón, 28223, Spain