The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
15 février 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
678
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Halfway, Afrique du Sud
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Pretoria, Afrique du Sud
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Barranquilla, Colombie
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Bogota, Colombie
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Busan, Corée, République de
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Goyang-Si, Corée, République de
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Jeonju-Si, Corée, République de
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Seoul, Corée, République de
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Wonju-Si, Corée, République de
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Alcala De Henares, Espagne
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Elche, Espagne
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Girona, Espagne
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Pozuelo De Alarcon, Espagne
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Pärnu, Estonie
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Tartu, Estonie
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Viljandi, Estonie
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Guatemala, Guatemala
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Bangalore, Inde
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Hyderabad, Inde
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Nagpur, Inde
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Reykjavik, Islande
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Horn, L'Autriche
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Salzburg, L'Autriche
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Wien, L'Autriche
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Kaunas, Lituanie
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Klaipeda, Lituanie
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Siauliai, Lituanie
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Vilnius, Lituanie
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Vilnius Lt, Lituanie
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Kelantan, Malaisie
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Kuala Lumpur, Malaisie
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Kuala Lumpur N/A, Malaisie
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Aguascalientes, Mexique
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Guadalajara, Mexique
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Mex, Mexique
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Monterrey, Mexique
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Zapopan, Mexique
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Makati, Philippines
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Manila, Philippines
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Marikina City, Philippines
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Pasay, Philippines
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Katowice, Pologne
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Torun, Pologne
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Warszawa, Pologne
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Fajardo, Porto Rico
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Ponce, Porto Rico
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San Juan, Porto Rico
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Baia Mare, Roumanie
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Brasov, Roumanie
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Bucharest, Roumanie
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Targu Mures, Roumanie
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Göteborg, Suède
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Lund, Suède
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Malmö, Suède
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Skene, Suède
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Arizona
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Phoenix, Arizona, États-Unis
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California
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Concord, California, États-Unis
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Greenbrae, California, États-Unis
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Los Angeles, California, États-Unis
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Spring Valley, California, États-Unis
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Colorado
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Colorado Springs, Colorado, États-Unis
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Denver, Colorado, États-Unis
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Northglenn, Colorado, États-Unis
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Illinois
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Springfield, Illinois, États-Unis
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Indiana
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Evansville, Indiana, États-Unis
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Louisiana
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Baton Rouge, Louisiana, États-Unis
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Metairie, Louisiana, États-Unis
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New Jersey
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Meridian, New Jersey, États-Unis
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New Mexico
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Albuquerque, New Mexico, États-Unis
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New York
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New York, New York, États-Unis
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West Seneca, New York, États-Unis
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North Carolina
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Mooresville, North Carolina, États-Unis
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Pennsylvania
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Perryopolis, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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South Carolina
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Taylors, South Carolina, États-Unis
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Texas
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Dallas, Texas, États-Unis
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Houston, Texas, États-Unis
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San Antonio, Texas, États-Unis
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Virginia
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Norfolk, Virginia, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in HbA1c From Baseline to Week 26 (Main Study)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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 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)
Délai: 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.
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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 (High Glycemic Substudy)
Délai: 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 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2010
Achèvement primaire (Réel)
1 août 2011
Achèvement de l'étude (Réel)
1 mars 2012
Dates d'inscription aux études
Première soumission
4 mars 2010
Première soumission répondant aux critères de contrôle qualité
4 mars 2010
Première publication (Estimation)
5 mars 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 février 2017
Dernière vérification
1 juin 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Inhibiteurs de protéase
- Incrétines
- Inhibiteurs du transporteur sodium-glucose 2
- Inhibiteurs de dipeptidyl-peptidase IV
- Phosphate de sitagliptine
- Canagliflozine
Autres numéros d'identification d'étude
- CR017011
- 28431754DIA3005 (Autre identifiant: Janssen Research & Development, LLC)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .