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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01809327
First received: March 8, 2013
Last updated: August 22, 2014
Last verified: August 2014

March 8, 2013
August 22, 2014
June 2013
December 2014   (final data collection date for primary outcome measure)
Change in glycated hemoglobin (HbA1c) from baseline to Week 26 [ Time Frame: Day 1 (Baseline) up to Week 26 ] [ Designated as safety issue: No ]
The change in HbA1c will be compared between the different treatment groups.
Same as current
Complete list of historical versions of study NCT01809327 on ClinicalTrials.gov Archive Site
  • Percent change in body weight from baseline to Week 26 [ Time Frame: Day 1 (Baseline) up to Week 26 ] [ Designated as safety issue: No ]
    The percent change in body weight will be compared between the different treatment groups.
  • Percentage of participants with glycated hemoglobin (HbAIc) less than 7 percent at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    The percentage of participants with HbAIc less than 7 percent will be compared between the different treatment groups.
  • Change in systolic blood pressure from baseline to Week 26 [ Time Frame: Day 1 (Baseline) up to Week 26 ] [ Designated as safety issue: No ]
    The change in systolic blood pressure will be compared between the different treatment groups.
  • Change in high-density lipoprotein cholesterol (HDL-C) from baseline to Week 26 [ Time Frame: Day 1 (Baseline) up to Week 26 ] [ Designated as safety issue: No ]
    The change in HDL-C will be compared between the different treatment groups.
  • Change in triglycerides from baseline to Week 26 [ Time Frame: Day 1 (Baseline) up to Week 26 ] [ Designated as safety issue: No ]
    The change in triglycerides will be compared between the different treatment groups.
  • Number of participants with adverse events [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events will be used as a measure of safety and tolerability.
Same as current
Not Provided
Not Provided
 
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
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

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

This study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of the treatments is an established effective treatment for type 2 diabetes mellitus), parallel-group (each group of participants will be treated at the same time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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: 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.
  • 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.
    Intervention: Drug: Canagliflozin 100 mg
  • 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.
    Intervention: Drug: Canagliflozin 300 mg
  • 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.
    Intervention: Drug: Metformin XR
  • 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.
    Interventions:
    • Drug: Canagliflozin 100 mg
    • Drug: Metformin XR
  • 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.
    Interventions:
    • Drug: Canagliflozin 300 mg
    • Drug: Metformin XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1186
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States,   Argentina,   Brazil,   Czech Republic,   Hungary,   Korea, Republic of,   Ukraine,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Turkey
 
NCT01809327
CR100034, 28431754DIA3011, 2011-000400-17
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
August 2014

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