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治験 NCT01966978 (SIMPLE)（対象：2型糖尿病、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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テキサス大学南西部医学センターThe Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study 第IV相・フェーズ4 157
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治験番号 NCT01966978 (SIMPLE) は 治療 の研究で、2型糖尿病、糖尿病 を対象とした 第IV相・フェーズ4 介入研究 臨床試験 でした。現在は 完了 です。2014年11月1日 に開始し、157 名の参加者 が参加しました。この試験は テキサス大学南西部医学センター によって主導され、2017年12月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2019年10月22日 です。
概要
The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).
詳細説明
The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician tim...もっと見る
公式タイトル
The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study
疾患名
2型糖尿病糖尿病刊行物
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
- SIMPLE
- STU 072013-030
NCT番号
開始日
2014-11
最終更新日
2019-10-22
終了予定日
2017-12
目標参加者数
157
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
完了
キーワード
Diabetes Mellitus, Type 2
Insulin
Insulin, Long-Acting
Insulin, Short Acting
Detemir
Liraglutide
GLP-1
Glucagon Like Peptide
Metformin
Uncontrolled Diabetes
Elevated A1c
Incretins
Insulin
Insulin, Long-Acting
Insulin, Short Acting
Detemir
Liraglutide
GLP-1
Glucagon Like Peptide
Metformin
Uncontrolled Diabetes
Elevated A1c
Incretins
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 |
|---|---|
実薬対照薬Control: Metformin, Insulin Detemir, Insulin Aspart Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician | メトホルミン Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day) Detemir Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed. Insulin Aspart Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG \<180 |
実薬対照薬Metformin, insulin determir, Liraglutide Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day) | メトホルミン Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day) Detemir Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed. Liraglutide Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean Change From Randomization in A1c at Week 26 | Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy | Baseline and Week 26 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Composite End-point | Percentage of participants with glycosylated Hemoglobin A1c (A1c)\<8% AND no documented severe hypoglycemia (\<56 mg/dL) during the study AND no significant weight gain (\>3% from baseline) | Week 0 (Randomization) , Week 26 |
Percentage of Participants Reaching Target A1c of <7% at Week 26 | Week 26 | |
Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome | Treatment Failure defined as A1c\>10% at week 13 (visit 5) | week 13 |
Mean Change From Randomization in Body Weight | Change in body weight from randomization to end of study. | Week 0 (Randomization) , Week 26 |
Hypoglycemic Episodes | Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of \<70 mg/dl | Week 0 (Randomization) , Week 2, week 4, week 13, Week 26 |
Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means | Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score. | Week 0 (Randomization) , Week 26 |
Change in Short Form-36 (SF-36) Questionnaire Score | Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains. | Week 0 (Randomization) , Week 26 |
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
1. Clinical diagnosis of type 2 diabetes with confirmed HbA1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
Age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
Clinical state requiring inpatient admission/treatment;
Contraindication or strong cautions to any of the study medications:
- Creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
- History of lactic acidosis (per metformin label)
- Advanced hepatic or cardiac disease (per metformin label)
- Age >80 years (per metformin label)
- Chronic alcohol use (>14 drinks/week)
- History of pancreatitis (per liraglutide label)
- Personal or family history of medullary thyroid cancer or MEN syndrome (per liraglutide label)
- Pregnancy and lactation (per liraglutide label)
Any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
Any scheduled elective procedures/surgeries;
Active infections, including osteomyelitis;
Not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to Randomization (visit 1)and the week prior to visit 6
Non English speaking.
テキサス大学南西部医学センター284 件のアクティブな治験を探索責任者
Ildiko Lingvay, 主任研究者, MD, University of Texas Southwestern Medical Center
連絡先情報がありません。
1 1カ国の場所
Texas
UT Southwestern Medical Center, Dallas, Texas, 02720, United States