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治験 NCT01377844（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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus 第II相・フェーズ2 288
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 NCT01377844 は 治療 の研究で、糖尿病 を対象とした 第II相・フェーズ2 介入研究 臨床試験 でした。現在は 完了 です。2011年12月1日 に開始し、288 名の参加者 が参加しました。この試験は Theracos によって主導され、2013年12月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2021年7月1日 です。
概要
The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the...もっと見る
詳細説明
EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the ...もっと見る
公式タイトル
Efficacy and Safety of EGT0001442 Compared With Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled by Diet and Exercise and up to One Oral Anti-diabetes Agent
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
- THR-1442-C-418
NCT番号
開始日
2011-12
最終更新日
2021-07-01
終了予定日
2013-12
目標参加者数
288
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
完了
キーワード
Diabetes mellitus
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
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的EGT0001442 EGT0001442 capsule, 20 mg, daily, 96 weeks | EGT0001442 |
プラセボ対照薬Placebo Placebo | プラセボ |
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 From Baseline in Hemoglobin A1c at 24 Weeks | Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment | Baseline and Week 24 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes in Systolic and Diastolic Blood Pressure at Week 24 | Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment | Baseline and Week 24 |
Changes in Body Weight at Week 24 | Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment | Baseline and week 24 |
Change From Baseline in HbA1c Over 96 Weeks Time | Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks. | Baseline and up to 96 weeks |
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) | Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment | 24 weeks |
Percentage of Subjects Achieving HbA1c <7% | The number and percentage of subjects achieving HbA1c response levels \<7% for the FAS using LOCF is reported | Baseline and up to 96 weeks |
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
- Male or female subjects ≥18 years old
- Diagnosed with type 2 diabetes
- Body mass index (BMI) ≤ 45 kg/m2
- HbA1c between 7 and 10% (inclusive) at screening
- FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies
- Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent
- If taking anti-diabetic medication, dose and regimen must be stable for past 3 months
- If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months
- If taking lipid modifying therapy, dose and regimen must be stable for past 3 months
- Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization
- Hemoglobinopathy that affects HbA1c measurement
- Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy)
- Genitourinary tract infection within 6 weeks of screening
- Greater than 2 episodes of genitourinary tract infection in the past year
- History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections
- eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 50 mL/min/1.73 m2
- Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN
- Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2
- Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >95)
- Not willing to use effective birth control, if female with child-bearing potential
- Life expectancy < 2 years
- New York Heart Association (NYHA) Class 4 heart failure
- Sera positive of HCV, HIV, or positive on drug screen
- Currently participating in another interventional trial
- Previous treatment with EGT0001442 or EGT0001474
- Not able to comply with the study scheduled visits
Theracos連絡先情報がありません。
11 1カ国の場所
California
Site 5, Buena Park, California, United States
Site 4, Los Angeles, California, United States
Site 3, Santa Ana, California, United States
Florida
Site 1, Hialeah, Florida, United States
New Jersey
Site 9, Berlin, New Jersey, United States
North Carolina
Site 7, Cary, North Carolina, United States
Ohio
Site 6, Marion, Ohio, United States
Site 8, Munroe Falls, Ohio, United States
Oregon
Site 2, Portland, Oregon, United States
Texas
Site 11, North Richland Hills, Texas, United States
Site 7, San Antonio, Texas, United States