An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Overview[ - collapse ][ - ]

Purpose 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 receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Canagliflozin 50 mg
Drug: Placebo
Drug: Canagliflozin 150 mg
Drug: Metformin
PhasePhase 2
SponsorJanssen Research & Development, LLC
Responsible PartyJanssen Research & Development, LLC
ClinicalTrials.gov IdentifierNCT01340664
First ReceivedApril 21, 2011
Last UpdatedMarch 5, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateApril 21, 2011
Last Updated DateMarch 5, 2014
Start DateJuly 2011
Estimated Primary Completion DateApril 2012
Current Primary Outcome Measures
  • Change in hemoglobin A1c from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Percentage of patients with adverse events as a measure of safety and tolerability [Time Frame: Up to week 18] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change in fasting plasma glucose from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Percentage of patients with hemoglobin A1c <7% (last observation carried forward) [Time Frame: Week 18] [Designated as safety issue: No]
  • Percentage of patients with hemoglobin A1c <6.5% (last observation carried forward) [Time Frame: Week 18] [Designated as safety issue: No]
  • Change in body mass index (BMI) from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in body weight from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in systolic blood pressure from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in diastolic blood pressure from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in high-density lipoprotein cholesterol (HDL-C) from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in triglycerides from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in total cholesterol from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]
  • Change in the ratio of low-density lipoprotein cholesterol (LDL-C) to high-density lipoprotein cholesterol (HDL-C) from baseline to week 18 (last observation carried forward) [Time Frame: Day 1 (Baseline) and Week 18] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleAn Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Official TitleA Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
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
receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have
inadequate glycemic (blood sugar) control.
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the patient nor
the study doctor will know the identity of assigned study drug), placebo-controlled,
parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy,
safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical
in appearance to canagliflozin but does not contain active drug) in patients with type 2
diabetes mellitus (T2DM) who are not achieving an adequate response from current
antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a
Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood
sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally
(by mouth) for 2 weeks before randomization. Patients will be randomly assigned
canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the
morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent
with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should
remain the same throughout the study.
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Canagliflozin 50 mg
One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
Drug: Placebo
1 placebo capsule taken orally twice daily with a meal for 18 weeks
Drug: Canagliflozin 150 mg
1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
Drug: Metformin
The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Study Arm (s)
  • Experimental: Canagliflozin 50 mg bid
    Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.
  • Experimental: Canagliflozin 150 mg bid
    Each patient will receive 150 mg canagliflozin twice daily for 18 weeks
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo twice daily for 18 weeks

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment279
Estimated Completion DateApril 2012
Estimated Primary Completion DateApril 2012
Eligibility Criteria
Inclusion Criteria:

- All patients must have a diagnosis of T2DM and be currently treated with metformin

- Patients in the study must have a HbA1c between >=7 and <=10.5%

- Patients must have 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, diabetes secondary to pancreatitis or pancreatectomy, or a
severe hypoglycemic episode within 6 months before screening
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada, Czech Republic, Mexico, Romania, Russian Federation, Slovakia

Administrative Information[ + expand ][ + ]

NCT Number NCT01340664
Other Study ID NumbersCR017914
Has Data Monitoring CommitteeYes
Information Provided ByJanssen Research & Development, LLC
Study SponsorJanssen Research & Development, LLC
CollaboratorsNot Provided
Investigators Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Verification DateMarch 2014

Locations[ + expand ][ + ]

United States, Arkansas
Little Rock, Arkansas, United States
United States, California
National City, California, United States
United States, California
Spring Valley, California, United States
United States, Florida
Bradenton, Florida, United States
United States, Florida
Marianna, Florida, United States
United States, Georgia
Savannah, Georgia, United States
United States, Indiana
Avon, Indiana, United States
United States, Indiana
Valparaiso, Indiana, United States
United States, Kentucky
Madisonville, Kentucky, United States
United States, Louisiana
Metairie, Louisiana, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Ohio
Mason, Ohio, United States
United States, Ohio
Perrysburg, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Oklahoma
Yukon, Oklahoma, United States
United States, Oregon
Oregon City, Oregon, United States
United States, Pennsylvania
Pittsburg, Pennsylvania, United States
United States, Rhode Island
East Providence, Rhode Island, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Texas
Pearland, Texas, United States
United States, Texas
San Antonio, Texas, United States
United States, Utah
Bountiful, Utah, United States
United States, Virginia
Virginia Beach, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Newfoundland and Labrador
St. John'S, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Brampton, Ontario, Canada
Canada, Ontario
Toronto, Ontario, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Czech Republic
Beroun, Czech Republic
Czech Republic
Olomouc 9, Czech Republic
Czech Republic
Ostrava, Czech Republic
Czech Republic
Pardubice, Czech Republic
Czech Republic
Pisek, Czech Republic
Czech Republic
Prague 10, Czech Republic
Czech Republic
Praha 11, Czech Republic
Czech Republic
Znojmo, Czech Republic
Mexico
Aguascalientes, Mexico
Mexico
Guadalajara, Jalisco., Mexico
Mexico
Monterrey, Mexico
Mexico
Tampico, Mexico
Romania
Bacau, Romania
Romania
Brasov, Romania
Romania
Bucharest, Romania
Romania
Cluj-Napoca, Romania
Romania
Galati, Romania
Romania
Targu Mures, Romania
Russian Federation
Kursk, Russian Federation
Russian Federation
Moscow, Russian Federation
Russian Federation
Saint-Petersburg, Russian Federation
Russian Federation
Samara, Russian Federation
Russian Federation
Saratov, Russian Federation
Russian Federation
St Petersburg, Russian Federation
Russian Federation
St-Petersburg, Russian Federation
Russian Federation
Tyumen, Russian Federation
Russian Federation
Voronezh, Russian Federation
Slovakia
Banska Bystrica, Slovakia
Slovakia
Bratislava, Slovakia
Slovakia
Kosice, Slovakia
Slovakia
Presov, Slovakia
Slovakia
Sahy, Slovakia
Slovakia
Trebisov, Slovakia