A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
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ClinicalTrials.gov Identifier: NCT01809327 |
Recruitment Status :
Completed
First Posted : March 12, 2013
Results First Posted : January 6, 2016
Last Update Posted : July 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Metformin XR | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1186 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise |
Actual Study Start Date : | June 4, 2013 |
Actual Primary Completion Date : | December 2, 2014 |
Actual Study Completion Date : | December 2, 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Canagliflozin 100 mg
Participants will receive one 100 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
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Drug: Canagliflozin 100 mg
One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm). |
Experimental: Canagliflozin 300 mg
Participants will receive one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
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Drug: Canagliflozin 300 mg
One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm). |
Experimental: Metformin XR
Participants will receive metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
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Drug: Metformin XR
One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal. |
Experimental: Canagliflozin 100 mg + Metformin XR
Participants will receive one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
|
Drug: Canagliflozin 100 mg
One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm). Drug: Metformin XR One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal. |
Experimental: Canagliflozin 300 mg + Metformin XR
Participants will receive one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
|
Drug: Canagliflozin 300 mg
One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm). Drug: Metformin XR One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal. |
- Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.
- Percent Change in Body Weight From Baseline to Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.
- Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26 [ Time Frame: Week 26 ]The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.
- Change in Systolic Blood Pressure From Baseline at Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.
- Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.
- Percent Change in Triglycerides From Baseline to Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.
- Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to 30 weeks of last study drug administration ]An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
- Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
- Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
- Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
- Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
- Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results

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): NCT01809327

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01809327 |
Other Study ID Numbers: |
CR100034 28431754DIA3011 ( Other Identifier: Janssen Research & Development, LLC ) 2011-000400-17 ( EudraCT Number ) |
First Posted: | March 12, 2013 Key Record Dates |
Results First Posted: | January 6, 2016 |
Last Update Posted: | July 11, 2017 |
Last Verified: | June 2017 |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 2 Diabetes Mellitus Canagliflozin (JNJ-28431754) Metformin |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin |
Canagliflozin Hypoglycemic Agents Physiological Effects of Drugs Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action |