The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
15 de fevereiro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
678
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Barranquilla, Colômbia
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Bogota, Colômbia
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Alcala De Henares, Espanha
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Elche, Espanha
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Girona, Espanha
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Pozuelo De Alarcon, Espanha
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Arizona
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Phoenix, Arizona, Estados Unidos
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California
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Concord, California, Estados Unidos
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Greenbrae, California, Estados Unidos
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Los Angeles, California, Estados Unidos
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Spring Valley, California, Estados Unidos
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Colorado
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Colorado Springs, Colorado, Estados Unidos
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Denver, Colorado, Estados Unidos
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Northglenn, Colorado, Estados Unidos
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Illinois
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Springfield, Illinois, Estados Unidos
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Indiana
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Evansville, Indiana, Estados Unidos
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos
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Metairie, Louisiana, Estados Unidos
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New Jersey
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Meridian, New Jersey, Estados Unidos
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New Mexico
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Albuquerque, New Mexico, Estados Unidos
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New York
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New York, New York, Estados Unidos
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West Seneca, New York, Estados Unidos
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North Carolina
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Mooresville, North Carolina, Estados Unidos
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Pennsylvania
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Perryopolis, Pennsylvania, Estados Unidos
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Pittsburgh, Pennsylvania, Estados Unidos
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South Carolina
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Taylors, South Carolina, Estados Unidos
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Texas
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Dallas, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Virginia
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Norfolk, Virginia, Estados Unidos
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Pärnu, Estônia
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Tartu, Estônia
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Viljandi, Estônia
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Makati, Filipinas
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Manila, Filipinas
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Marikina City, Filipinas
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Pasay, Filipinas
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Guatemala, Guatemala
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Reykjavik, Islândia
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Kaunas, Lituânia
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Klaipeda, Lituânia
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Siauliai, Lituânia
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Vilnius, Lituânia
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Vilnius Lt, Lituânia
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Kelantan, Malásia
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Kuala Lumpur, Malásia
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Kuala Lumpur N/A, Malásia
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Aguascalientes, México
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Guadalajara, México
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Mex, México
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Monterrey, México
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Zapopan, México
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Katowice, Polônia
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Torun, Polônia
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Warszawa, Polônia
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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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Busan, Republica da Coréia
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Goyang-Si, Republica da Coréia
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Jeonju-Si, Republica da Coréia
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Seoul, Republica da Coréia
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Wonju-Si, Republica da Coréia
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Baia Mare, Romênia
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Brasov, Romênia
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Bucharest, Romênia
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Targu Mures, Romênia
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Göteborg, Suécia
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Lund, Suécia
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Malmö, Suécia
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Skene, Suécia
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Halfway, África do Sul
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Pretoria, África do Sul
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Horn, Áustria
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Salzburg, Áustria
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Wien, Áustria
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Bangalore, Índia
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Hyderabad, Índia
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Nagpur, Índia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in HbA1c From Baseline to Week 26 (Main Study)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2010
Conclusão Primária (Real)
1 de agosto de 2011
Conclusão do estudo (Real)
1 de março de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
4 de março de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2010
Primeira postagem (Estimativa)
5 de março de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de fevereiro de 2017
Última verificação
1 de junho de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do Sistema Endócrino
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 2
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Inibidores de Protease
- Incretinas
- Inibidores do transportador de sódio-glicose 2
- Inibidores de Dipeptidil-Peptidase IV
- Fosfato de Sitagliptina
- Canagliflozina
Outros números de identificação do estudo
- CR017011
- 28431754DIA3005 (Outro identificador: Janssen Research & Development, LLC)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .