The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
2017年2月15日 更新者：Janssen Research & Development, LLC
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
調査の概要
詳細な説明
Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM).
This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3 arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes.
Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study).
Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study).
The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise.
Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks.
During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information.
Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified.
Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy.
研究の種類
介入
入学 (実際)
678
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Reykjavik、アイスランド
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Arizona
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Phoenix、Arizona、アメリカ
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California
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Concord、California、アメリカ
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Greenbrae、California、アメリカ
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Los Angeles、California、アメリカ
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Spring Valley、California、アメリカ
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Colorado
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Colorado Springs、Colorado、アメリカ
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Denver、Colorado、アメリカ
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Northglenn、Colorado、アメリカ
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Illinois
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Springfield、Illinois、アメリカ
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Indiana
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Evansville、Indiana、アメリカ
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Louisiana
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Baton Rouge、Louisiana、アメリカ
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Metairie、Louisiana、アメリカ
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New Jersey
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Meridian、New Jersey、アメリカ
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New Mexico
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Albuquerque、New Mexico、アメリカ
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New York
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New York、New York、アメリカ
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West Seneca、New York、アメリカ
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North Carolina
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Mooresville、North Carolina、アメリカ
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Pennsylvania
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Perryopolis、Pennsylvania、アメリカ
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Pittsburgh、Pennsylvania、アメリカ
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South Carolina
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Taylors、South Carolina、アメリカ
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Texas
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Dallas、Texas、アメリカ
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Houston、Texas、アメリカ
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San Antonio、Texas、アメリカ
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Virginia
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Norfolk、Virginia、アメリカ
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Bangalore、インド
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Hyderabad、インド
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Nagpur、インド
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Pärnu、エストニア
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Tartu、エストニア
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Viljandi、エストニア
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Horn、オーストリア
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Salzburg、オーストリア
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Wien、オーストリア
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Guatemala、グアテマラ
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Barranquilla、コロンビア
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Bogota、コロンビア
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Göteborg、スウェーデン
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Lund、スウェーデン
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Malmö、スウェーデン
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Skene、スウェーデン
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Alcala De Henares、スペイン
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Elche、スペイン
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Girona、スペイン
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Pozuelo De Alarcon、スペイン
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Makati、フィリピン
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Manila、フィリピン
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Marikina City、フィリピン
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Pasay、フィリピン
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Fajardo、プエルトリコ
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Ponce、プエルトリコ
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San Juan、プエルトリコ
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Katowice、ポーランド
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Torun、ポーランド
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Warszawa、ポーランド
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Kelantan、マレーシア
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Kuala Lumpur、マレーシア
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Kuala Lumpur N/A、マレーシア
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Aguascalientes、メキシコ
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Guadalajara、メキシコ
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Mex、メキシコ
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Monterrey、メキシコ
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Zapopan、メキシコ
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Kaunas、リトアニア
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Klaipeda、リトアニア
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Siauliai、リトアニア
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Vilnius、リトアニア
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Vilnius Lt、リトアニア
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Baia Mare、ルーマニア
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Brasov、ルーマニア
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Bucharest、ルーマニア
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Targu Mures、ルーマニア
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Halfway、南アフリカ
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Pretoria、南アフリカ
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Busan、大韓民国
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Goyang-Si、大韓民国
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Jeonju-Si、大韓民国
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Seoul、大韓民国
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Wonju-Si、大韓民国
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- All patients must have a diagnosis of T2DM
- Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
- Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
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：Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
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One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
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実験的：Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
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One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
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実験的：Placebo/Sitagliptin
In the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.
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One matching placebo capsule orally once daily for 26 weeks (Main Study)
One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
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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 |
メジャーの説明 |
時間枠 |
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Change in HbA1c From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
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Day 1 (Baseline) and Week 26
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Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
時間枠：Week 26
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The table below shows the percentage of patients with HbA1c <7% at Week 26.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
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Week 26
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
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Day 1 (Baseline) and Week 26
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Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
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Day 1 (Baseline) and Week 26
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Percent Change in Body Weight From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
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Day 1 (Baseline) and Week 26
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Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
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Day 1 (Baseline) and Week 26
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Percent Change in Triglycerides From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
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Day 1 (Baseline) and Week 26
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Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group.
The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.
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Day 1 (Baseline) and Week 26
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Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)
時間枠：Week 26
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The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Week 26
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
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Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
|
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
|
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Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
|
Day 1 (Baseline) and Week 26
|
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Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
|
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
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Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
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Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)
時間枠：Day 1 (Baseline) and Week 26
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The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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Day 1 (Baseline) and Week 26
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.
- Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.
- Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.
- Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.
- John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.
- Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
- Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.
- Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.
- Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.
- Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.
- Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.
- Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
- Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.
- Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
- Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.
- Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.
- Stenlof K, Cefalu WT, Kim KA, Jodar E, Alba M, Edwards R, Tong C, Canovatchel W, Meininger G. Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study. Curr Med Res Opin. 2014 Feb;30(2):163-75. doi: 10.1185/03007995.2013.850066. Epub 2013 Oct 28.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年3月1日
一次修了 (実際)
2011年8月1日
研究の完了 (実際)
2012年3月1日
試験登録日
最初に提出
2010年3月4日
QC基準を満たした最初の提出物
2010年3月4日
最初の投稿 (見積もり)
2010年3月5日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月23日
QC基準を満たした最後の更新が送信されました
2017年2月15日
最終確認日
2013年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CR017011
- 28431754DIA3005 (その他の識別子：Janssen Research & Development, LLC)
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。