TOFO Insulin Combination Trial
A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
- Body weight
- Fasting plasma glucose (FPG)
- Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Adachi-ku、日本
- Investigational Site Number 392-028
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Atsugi-shi、日本
- Investigational Site Number 392-007
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Chuoh-ku、日本
- Investigational Site Number 392-026
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Fukuoka-shi、日本
- Investigational Site Number 392-021
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Ichihara-shi、日本
- Investigational Site Number 392-002
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Iruma-shi、日本
- Investigational Site Number 392-012
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Kawaguchi-shi、日本
- Investigational Site Number 392-003
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Kitakyusyu-shi、日本
- Investigational Site Number 392-014
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Kobe-shi、日本
- Investigational Site Number 392-027
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Koga-shi、日本
- Investigational Site Number 392-004
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Kunitachi-shi、日本
- Investigational Site Number 392-022
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Kurume-shi、日本
- Investigational Site Number 392-019
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Kyoto-shi、日本
- Investigational Site Number 392-001
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Kyoto-shi、日本
- Investigational Site Number 392-024
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Matsudo-shi、日本
- Investigational Site Number 392-006
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Mito-shi、日本
- Investigational Site Number 392-008
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Musashino-shi、日本
- Investigational Site Number 392-030
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Okayama-shi、日本
- Investigational Site Number 392-029
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Otsu-shi、日本
- Investigational Site Number 392-017
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Sagamihara-shi、日本
- Investigational Site Number 392-011
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Sakai-shi、日本
- Investigational Site Number 392-020
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Sapporo-shi、日本
- Investigational Site Number 392-010
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Sendai-shi、日本
- Investigational Site Number 392-016
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Shinjuku-ku、日本
- Investigational Site Number 392-018
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Shizuoka-shi、日本
- Investigational Site Number 392-005
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Suita-shi、日本
- Investigational Site Number 392-031
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Sumida-ku、日本
- Investigational Site Number 392-015
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Sunto-gun、日本
- Investigational Site Number 392-023
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Tokorozawa-shi、日本
- Investigational Site Number 392-013
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Yokohama-shi、日本
- Investigational Site Number 392-025
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
- Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
- Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
- Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
- Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
- Body mass index (BMI) ≥18.5 kg/m^2 and <35.0 kg/m^2.
- No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.
Exclusion criteria:
- Type 1 diabetes mellitus.
- Pregnancy or lactation.
- Severely uncontrolled glycemic situation.
- History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
- History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
- A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
- Has previously received treatment with the investigational product.
- Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
- Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical [skin] application, eye drops and sprays).
- Patients who are frequently experiencing orthostatic hypotension.
- Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
- Lipid-lowering drug
- Antihypertensive drug
- Thyroid hormone preparation
- Uric acid lowering drug
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:tofogliflozin
Tofogliflozin administered once daily for 52 weeks.
Insulin administered as base treatment.
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Pharmaceutical form:tablet Route of administration: oral
他の名前:
Pharmaceutical form:solution Route of administration: subcutaneous
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プラセボコンパレーター:placebo
Placebo administered once daily for 16 weeks.
After 16-weeks, Tofogliflozin administered once daily for 36 weeks.
Insulin administered as base treatment.
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Pharmaceutical form:tablet Route of administration: oral
他の名前:
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Change in HbA1c from baseline
時間枠:16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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二次結果の測定
結果測定 |
時間枠 |
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Change of Body Weight (BW) from baseline
時間枠:16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of FPG from baseline
時間枠:16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of PPG from baseline
時間枠:16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Number of subjects with adverse events
時間枠:Up to 52 weeks from the first intake of investigational medicinal product
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Up to 52 weeks from the first intake of investigational medicinal product
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TOFOGL07061
- U1111-1159-5316 (UTN)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
2型糖尿病の臨床試験
TOFOGLIFLOZIN CSG452の臨床試験
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Kowa Research Institute, Inc.完了
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Kowa Research Institute, Inc.募集