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治験 NCT00135941（対象：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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サノフィInsulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) 第III相・フェーズ3 582
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 NCT00135941 は 治療 の研究で、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。2005年8月1日 に開始し、582 名の参加者 が参加しました。この試験は サノフィ によって主導され、2007年9月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2009年6月4日 です。
概要
The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.
公式タイトル
Insulin Glargine Plus Insulin Glulisine MDI Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2) Evaluating Differences in Patient Reported Outcomes
疾患名
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
- HMR1964A_3508
NCT番号
開始日
2005-08
最終更新日
2009-06-04
終了予定日
2007-09
目標参加者数
582
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
完了
キーワード
Diabetes Mellitus, Type 2
主目的
治療
割付方法
無作為化
介入モデル
クロスオーバー法
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1 Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks. | insulin glargine Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks. |
実験的2 Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks. | insulin glulisine Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To compare improvements from baseline in patient reported outcomes (quality of life, treatment satisfaction) when aggressively treated with insulin glargine plus rapid acting insulin glulisine vs treatment with Premix insulin | 24 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
change in A1c (baseline to week 24), reported hypo events (throughout the trials), correlation between patient reported outcomes and glucose variability as measured by CGMS (baseline, week 8 and week 20). | 24 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
21 Years
対象性別
全て
- Informed consent in writing at enrollment
- Subjects with type 1 or type 2 diabetes mellitus for at least six months
- Male or female 21 - 70 years of age
- Employed, unpaid work or active lifestyle
- Screening hemoglobin A1c (HbA1c) level of ≥ 7.0 and ≤ 9.0 %
- Current (last 3 months) daily use of premix insulin 75/25, 70/30, or isophane insulin (NPH) or Lantus with short acting insulin, consisting of 2 or more injections per day with or without concomitant therapy consisting of metformin, thiazolidinedione, and/or alpha-glucosidase inhibitors.
- Willing and able to inject insulin glargine and multi-day dosing of insulin glulisine.
- Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
- Willing and able to use adequate contraception if of child bearing age
- Able to read and understand English (at the sixth grade level) and comply with the study protocol
- Cardiac status New York Heart Association (NYHA) III-IV
- Serum creatinine ≥ 1.5 mg/dl for males, or ≥ 1.4 mg/dl for females.
- Clinical evidence of active liver disease or serum ALT or AST > 2.5 times the upper limit of normal range.
- Subjects currently using an insulin pump
- Subjects currently taking sulfonylureas, repaglinide, nateglinide, symlin (pramlintide acetate) or byetta (exenatide).
- Planned pregnancy in next 6 months or pregnant or lactating females
- Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Unable to obtain complete CGMS data prior to baseline, visit 2 (week 0)
- Hypersensitivity to insulin glargine or insulin glulisine or premix insulin or any of their components
- Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
- Treatment with intermittent doses of systemic steroids or intermittent large doses of inhaled steroids for the past one year (treatment with fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regimen)
- Treatment with any investigational product in the last 3 months before study entry
- Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or unstable angina pectoris within the last 12 months
- Current malignancy, any previous breast cancer, any previous malignant melanoma or any cancer within the past 5 years (except adequately treated basal cell skin cancer)
サノフィ連絡先情報がありません。
1 1カ国の場所
Wisconsin
Advanced Healthcare, Milwaukee, Wisconsin, 53209, United States