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An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642278
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : May 17, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE March 21, 2008
First Posted Date  ICMJE March 25, 2008
Results First Submitted Date  ICMJE April 1, 2013
Results First Posted Date  ICMJE May 17, 2013
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
Change in HbA1c From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]
The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
The primary efficacy endpoint is the change in hemoglobin A1c (A1C) from baseline through Week 12.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]
    The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
  • Percentage of Patients With Symptoms of Hypoglycemia [ Time Frame: Up to Week 12 ]
    The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.
  • Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]
    The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
  • Absolute Change in Body Weight From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]
    The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.
  • Percent Change in Body Weight From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]
    The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
The change in A1C from baseline to Weeks 6, 9, and 12; the proportion of subjects with A1C of <6.5% and <7.0% at Week 12; the change in 7-point self-monitored blood glucose profiles from baseline to Week 6 and 12
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm
Brief Summary The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Detailed Description Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type II
  • Diabetes Mellitus, Non Insulin Dependent
Intervention  ICMJE
  • Drug: Canagliflozin (JNJ-28431754)
    One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
    Other Name: JNJ-28431754
  • Drug: Sitagliptin
    One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
  • Drug: Placebo
    One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
Study Arms  ICMJE
  • Experimental: Canagliflozin 50 mg daily
    Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Placebo
  • Experimental: Canagliflozin 100 mg daily
    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Placebo
  • Experimental: Canagliflozin 200 mg daily
    Each patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Placebo
  • Experimental: Canagliflozin 300 mg daily
    Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening).
    Interventions:
    • Drug: Canagliflozin (JNJ-28431754)
    • Drug: Placebo
  • Experimental: Canagliflozin 300 mg twice daily
    Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
    Intervention: Drug: Canagliflozin (JNJ-28431754)
  • Active Comparator: Sitagliptin 100 mg daily
    Each patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
    Interventions:
    • Drug: Sitagliptin
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo twice daily for 12 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2009)
451
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2008)
420
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have a diagnosis of type 2 diabetes mellitus
  • Hemoglobin A1c levels >=7% and <=10.5%
  • taking a stable daily dose of metformin
  • Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
  • Stable body weight
  • Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women

Exclusion Criteria:

  • Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
  • Known contraindication or suspected hypersensitivity to sitagliptin or metformin
  • A history of diabetic ketoacidosis or type 1 diabetes mellitus
  • History of pancreas or beta-cell transplantation
  • History of active proliferative diabetic retinopathy
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Canada,   Czech Republic,   India,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   United Kingdom,   United States
Removed Location Countries Ireland,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT00642278
Other Study ID Numbers  ICMJE CR014587
28431754DIA2001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP