An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00642278 |
Recruitment Status :
Completed
First Posted : March 25, 2008
Results First Posted : May 17, 2013
Last Update Posted : July 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type II Diabetes Mellitus, Non Insulin Dependent | Drug: Canagliflozin (JNJ-28431754) Drug: Sitagliptin Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 451 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
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).
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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: Placebo One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. |
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).
|
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: Placebo One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. |
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).
|
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: Placebo One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. |
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).
|
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: Placebo One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. |
Experimental: Canagliflozin 300 mg twice daily
Each patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
|
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 |
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).
|
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. |
Placebo Comparator: Placebo
Each patient will receive matching placebo twice daily for 12 weeks.
|
Drug: Placebo
One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks. |
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642278

Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00642278 |
Other Study ID Numbers: |
CR014587 28431754DIA2001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ) |
First Posted: | March 25, 2008 Key Record Dates |
Results First Posted: | May 17, 2013 |
Last Update Posted: | July 19, 2013 |
Last Verified: | July 2013 |
Type 2 diabetes mellitus Metformin Hemoglobin A1c |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Phosphate Canagliflozin Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Sodium-Glucose Transporter 2 Inhibitors |