The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

NCT ID: NCT01106690

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-07-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

Detailed Description

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 (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 with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. 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 capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo/Sitagliptin

Each patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.

Group Type: OTHER

Placebo

Intervention Type: DRUG

One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.

Sitagliptin

Intervention Type: DRUG

One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.

Metformin

Intervention Type: DRUG

The patient's stable dose of metformin background therapy should be continued throughout the study.

Pioglitazone

Intervention Type: DRUG

The patient's stable dose of pioglitazone background therapy should be continued throughout the study.

Canagliflozin 100 mg

Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Group Type: EXPERIMENTAL

Canagliflozin

Intervention Type: DRUG

One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.

Metformin

Intervention Type: DRUG

The patient's stable dose of metformin background therapy should be continued throughout the study.

Pioglitazone

Intervention Type: DRUG

The patient's stable dose of pioglitazone background therapy should be continued throughout the study.

Canagliflozin 300 mg

Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Group Type: EXPERIMENTAL

Canagliflozin

Intervention Type: DRUG

One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.

Metformin

Intervention Type: DRUG

The patient's stable dose of metformin background therapy should be continued throughout the study.

Pioglitazone

Intervention Type: DRUG

The patient's stable dose of pioglitazone background therapy should be continued throughout the study.

Interventions

Placebo

One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.

Intervention Type: DRUG

Canagliflozin

One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.

Intervention Type: DRUG

Sitagliptin

One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.

Intervention Type: DRUG

Metformin

The patient's stable dose of metformin background therapy should be continued throughout the study.

Intervention Type: DRUG

Pioglitazone

The patient's stable dose of pioglitazone background therapy should be continued throughout the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
• Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Exclusion Criteria

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• or a severe hypoglycemic episode within 6 months before screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Anniston, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Burlingame, California, United States

Encinitas, California, United States

Fullerton, California, United States

Roseville, California, United States

Santa Ana, California, United States

Wes Hills, California, United States

Colorado Springs, Colorado, United States

Bartow, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Pembroke Pines, Florida, United States

Des Moines, Iowa, United States

Baton Rouge, Louisiana, United States

Chaska, Minnesota, United States

Picayune, Mississippi, United States

Billings, Montana, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Raleigh, North Carolina, United States

Dublin, Ohio, United States

Perrysburg, Ohio, United States

Tulsa, Oklahoma, United States

Yukon, Oklahoma, United States

Bensalem, Pennsylvania, United States

Bristol, Tennessee, United States

Kingsport, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Dallas, Texas, United States

Grand Prairie, Texas, United States

Houston, Texas, United States

New Braunfels, Texas, United States

San Antonio, Texas, United States

Falls Church, Virginia, United States

Virginia Beach, Virginia, United States

Federal Way, Washington, United States

Selah, Washington, United States

Bathurst, New Brunswick, Canada

Moncton, New Brunswick, Canada

Grand Falls-Windsor, Newfoundland and Labrador, Canada

Brampton, Ontario, Canada

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Smiths Falls, Ontario, Canada

Thornhill, Ontario, Canada

Drummondville, Quebec, Canada

Calgary, , Canada

Mount Pearl, , Canada

Truro, , Canada

Kuopio, , Finland

Oulu, , Finland

Turku, , Finland

Bondy, , France

Le Creusot, , France

Narbonne, , France

Aschaffenburg, , Germany

Mainz, , Germany

Neuwied, , Germany

Schkeuditz, , Germany

Athens, , Greece

Thessaloniki, , Greece

Thessalonikis, , Greece

Ahmedabad, , India

Belagavi, , India

Chennai, , India

Coimbatore, , India

Jaipur, , India

Nagpur, , India

Chihuahua City, , Mexico

Ciudad Juárez, , Mexico

Durango, , Mexico

México, , Mexico

Almería, , Spain

Madrid, , Spain

Seville, , Spain

Bangkok, , Thailand

Khon Kaen, , Thailand

Antrim, , United Kingdom

Belfast, , United Kingdom

Countries

United States; Canada; Finland; France; Germany; Greece; India; Mexico; Spain; Thailand; United Kingdom

References

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PMID: 28241822 (View on PubMed)

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Reference Type: DERIVED

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Other Identifiers

28431754DIA3012

Identifier Type: OTHER

Identifier Source: secondary_id

CR017032

Identifier Type: -

Identifier Source: org_study_id