CClinicalTrials.gg
Sign In
CompletedNCT01809327Updated Jul 11, 2017Results posted

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 Phase 3 interventional study of Canagliflozin 100 mg and Canagliflozin 300 mg in Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development, LLC. Completed at 137 sites in 13 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,186
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Canagliflozin (JNJ-28431754)
  • Metformin
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 1,186 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,186 participants (actual)

Study arms

  • 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.

    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.

    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.

    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.

    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.

    Drug: Canagliflozin 300 mg · Drug: Metformin XR

Interventions

  • DrugCanagliflozin 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).

  • DrugCanagliflozin 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).

  • DrugMetformin 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.

06

What researchers measure

Primary outcomes

  1. Change in Glycated Hemoglobin (HbA1c) From Baseline at 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.

    Time frame: Day 1 (Baseline) and Week 26

Secondary outcomes

  1. Percent Change in Body Weight From Baseline to Week 26

    The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.

    Time frame: Day 1 (Baseline) and Week 26

  2. Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26

    The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.

    Time frame: Week 26

  3. Change in Systolic Blood Pressure From Baseline at Week 26

    The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.

    Time frame: Day 1 (Baseline) and Week 26

  4. Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to 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.

    Time frame: Day 1 (Baseline) and Week 26

  5. Percent Change in Triglycerides From Baseline to Week 26

    The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.

    Time frame: Day 1 (Baseline) and Week 26

  6. Number of Participants With Treatment Emergent Adverse Events (AEs)

    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.

    Time frame: Up to 30 weeks of last study drug administration

07

Results

Posted Jan 6, 2016

Participant flow

The study was conducted between 16 May 2013 and 01 December 2014 and recruited participants from 158 study centers in 12 countries worldwide.

Participant flow — Overall Study
MilestoneMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Started237237238237237
Completed205211216225212
Not completed3226221225
Withdrew: Lost to follow-up52423
Withdrew: Withdrawal by subject64425
Withdrew: Adverse event43748
Withdrew: Death10000
Withdrew: Protocol violation01000
Withdrew: Physician decision11000
Withdrew: Pregnancy10000
Withdrew: Other1415749

Outcome measures

PrimaryChange in Glycated Hemoglobin (HbA1c) From Baseline at 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · percentage of hemoglobin
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
percentage of hemoglobinMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26-1.30 ± 0.071-1.37 ± 0.071-1.42 ± 0.070-1.77 ± 0.069-1.78 ± 0.070
Statistical analysis
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.46 · 95% CI -0.657 to -0.269
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.48 · 95% CI -0.670 to -0.280
  • Canagliflozin 100 Milligram (mg) vs Canagliflozin 100 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.40 · 95% CI -0.594 to -0.207
  • Canagliflozin 300 mg vs Canagliflozin 300 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.36 · 95% CI -0.557 to -0.169
  • Metformin XR vs Canagliflozin 100 Milligram (mg) · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.06 · 95% CI -0.258 to 0.133
  • Metformin XR vs Canagliflozin 300 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -0.11 · 95% CI -0.307 to 0.082
SecondaryPercent Change in Body Weight From Baseline to Week 26

The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · percent change
Percent Change in Body Weight From Baseline to Week 26
percent changeMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Percent Change in Body Weight From Baseline to Week 26-2.1 ± 0.3-3.0 ± 0.3-3.9 ± 0.3-3.5 ± 0.3-4.2 ± 0.3
Statistical analysis
  • Metformin XR vs Canagliflozin 100 Milligram (mg) · Mixed Model for Repeated Measures (MMRM) · p = 0.016 · Least-squares mean difference: -0.9 · 95% CI -1.6 to -0.2
  • Metformin XR vs Canagliflozin 300 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.002 · Least-squares mean difference: -1.8 · 95% CI -2.6 to -1.1
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -1.4 · 95% CI -2.1 to -0.6
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.001 · Least-squares mean difference: -2.1 · 95% CI -2.9 to -1.4
SecondaryPercentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26

The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.

Time frame:
Week 26
Reported as:
Number · percentage of participants
Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26
percentage of participantsMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 2643.038.842.849.656.8
Statistical analysis
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · Generalized Linear Mixed Model · p = 0.027 · Odds ratio (or): 1.58 · 95% CI 1.06 to 2.37
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · Generalized Linear Mixed Model · p = 0.016 · Odds ratio (or): 2.21 · 95% CI 1.46 to 3.33
SecondaryChange in Systolic Blood Pressure From Baseline at Week 26

The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · millimeter of mercury (mm Hg)
Change in Systolic Blood Pressure From Baseline at Week 26
millimeter of mercury (mm Hg)Metformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Change in Systolic Blood Pressure From Baseline at Week 26-0.33 ± 0.633-2.24 ± 0.627-2.36 ± 0.622-2.24 ± 0.613-1.65 ± 0.624
Statistical analysis
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.060 · Least-squares mean difference: -1.91 · 95% CI -3.641 to -0.182
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · Mixed Model for Repeated Measures (MMRM) · p = 0.147 · Least-squares mean difference: -1.31 · 95% CI -3.058 to 0.431
SecondaryPercent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to 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.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Least squares mean · percent change
Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
percent changeMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 2610.2 ± 1.517.6 ± 1.516.6 ± 1.515.5 ± 1.514.5 ± 1.5
Statistical analysis
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · ANCOVA · p = 0.147 · Least-squares mean difference: 5.3 · 95% CI 1.2 to 9.5
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · ANCOVA · p = 0.147 · Least-squares mean difference: 4.3 · 95% CI 0.2 to 8.5
SecondaryPercent Change in Triglycerides From Baseline to Week 26

The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.

Time frame:
Day 1 (Baseline) and Week 26
Reported as:
Mean · percent change
Percent Change in Triglycerides From Baseline to Week 26
percent changeMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Percent Change in Triglycerides From Baseline to Week 2613.6 ± 51.81.7 ± 50.52.8 ± 60.313.0 ± 81.921.2 ± 71.1
Statistical analysis
  • Metformin XR vs Canagliflozin 100 mg + Metformin XR · Wilcoxon (Mann-Whitney) · p = 0.608 · Hodges-lehman estimate: -3.7 · 95% CI -11.1 to 3.4
  • Metformin XR vs Canagliflozin 300 mg + Metformin XR · Wilcoxon (Mann-Whitney) · p = 0.806 · Hodges-lehman estimate: 1.3 · 95% CI -7.3 to 10.0
SecondaryNumber of Participants With Treatment Emergent Adverse Events (AEs)

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.

Time frame:
Up to 30 weeks of last study drug administration
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events (AEs)
participantsMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Number of Participants With Treatment Emergent Adverse Events (AEs)89889599105

Adverse events

Collected over Up to 30 weeks of last study drug administration. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Metformin XR—7/237 (3%)37/237 (15.6%)
Canagliflozin 100 Milligram (mg)—4/237 (1.7%)38/237 (16%)
Canagliflozin 300 mg—7/238 (2.9%)38/238 (16%)
Canagliflozin 100 mg + Metformin XR—7/237 (3%)42/237 (17.7%)
Canagliflozin 300 mg + Metformin XR—4/237 (1.7%)43/237 (18.1%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
Angina PectorisCardiac disorders0/2370/2372/2380/2370/237
SyncopeNervous system disorders0/2370/2372/2380/2370/237
AnaemiaBlood and lymphatic system disorders0/2371/2370/2380/2370/237
Immune Thrombocytopenic PurpuraBlood and lymphatic system disorders0/2371/2370/2380/2370/237
Angina UnstableCardiac disorders0/2370/2370/2381/2370/237
ArrhythmiaCardiac disorders0/2371/2370/2380/2370/237
Coronary Artery DiseaseCardiac disorders0/2371/2370/2381/2370/237
GoitreEndocrine disorders0/2370/2370/2381/2370/237
DiverticulumGastrointestinal disorders1/2370/2370/2380/2370/237
Epiploic AppendagitisGastrointestinal disorders1/2370/2370/2380/2370/237
Most frequent other events
Showing 10 of 13
Most frequent other events
EventMetformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XR
DiarrhoeaGastrointestinal disorders3/2373/2374/23810/23710/237
NasopharyngitisInfections and infestations3/2379/2379/2386/2373/237
HeadacheNervous system disorders8/2374/2374/2389/2377/237
InfluenzaInfections and infestations5/2376/2375/2388/2377/237
Urinary Tract InfectionInfections and infestations3/2373/2374/2382/2377/237
NauseaGastrointestinal disorders6/2371/2372/2381/2372/237
Upper Respiratory Tract InfectionInfections and infestations6/2372/2376/2383/2374/237
Glomerular Filtration Rate DecreasedInvestigations0/2376/2373/2381/2372/237
HyperglycaemiaMetabolism and nutrition disorders6/2375/2371/2380/2372/237
Back PainMusculoskeletal and connective tissue disorders4/2373/2375/2386/2375/237

Baseline characteristics

Age, Continuous
Age, Continuous(years)Metformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XRTotal
Mean55.2 ± 9.7554.0 ± 10.7055.8 ± 9.5654.2 ± 9.5855.4 ± 9.8454.9 ± 9.91
Sex: Female, Male
Sex: Female, Male(Participants)Metformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XRTotal
Female121132113129122617
Male116105125108115569
Region of Enrollment
Region of Enrollment(participants)Metformin XRCanagliflozin 100 Milligram (mg)Canagliflozin 300 mgCanagliflozin 100 mg + Metformin XRCanagliflozin 300 mg + Metformin XRTotal
Argentina121921172089
Brazil121004
Czech Republic8666834
Hungary2589428
Mexico3331193838159
Romania2416212714102
Russian Federation3838454437202
Slovakia1712229969
South Africa5545322
South Korea4221312
Ukraine5056424054242
United States4345474147223
08

Study locations

137 sites
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Encinitas, California, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • Norwalk, California, United States
  • Rancho Cucamonga, California, United States
  • Walnut Creek, California, United States
  • Denver, Colorado, United States
  • Northglenn, Colorado, United States
  • Hialeah, Florida, United States
  • Miami, Florida, United States
  • New Port Richey, Florida, United States
  • Opa-locka, Florida, United States
  • Perry, Georgia, United States
  • Evansville, Indiana, United States
  • Mandeville, Louisiana, United States
  • Metairie, Louisiana, United States
  • Sunset, Louisiana, United States
  • Flint, Michigan, United States
  • Kalamazoo, Michigan, United States
  • Royal Oak, Michigan, United States
  • Troy, Michigan, United States
  • Olive Branch, Mississippi, United States
  • Picayune, Mississippi, United States
  • Albuquerque, New Mexico, United States
  • West Seneca, New York, United States
  • Hickory, North Carolina, United States
  • Mooresville, North Carolina, United States
  • Franklin, Ohio, United States
  • Mason, Ohio, United States
  • Perrysburg, Ohio, United States
  • Zanesville, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Yukon, Oklahoma, United States
  • Tualatin, Oregon, United States
  • Fleetwood, Pennsylvania, United States
  • Norristown, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Rapid City, South Dakota, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Pearland, Texas, United States
  • Plano, Texas, United States
  • Bountiful, Utah, United States
  • Salt Lake City, Utah, United States
  • Danville, Virginia, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma De Buenos Aires, Argentina
  • Cordoba, Argentina
  • Mar Del Plata, Argentina
  • Moron, Argentina
  • Rosario, Argentina
  • Zarate, Argentina
  • Passo Fundo, Brazil
  • Sao Paulo, Brazil
  • São Paulo, Brazil
  • Kromeriz, Czechia
  • Pardubice, Czechia
  • Praha 8, Czechia
  • Praha, Czechia
  • Unicov, Czechia
  • Balatonfured, Hungary
  • Budapest, Hungary
  • Eger, Hungary
  • Szikszó, Hungary
  • Zalaegerszeg, Hungary
  • Goyang-Si, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
  • Celaya, Mexico
  • Durango, Mexico
  • Guadalajara, Mexico
  • Mexico, Mexico
  • Monterrey, Mexico
  • Pachuca De Soto, Mexico
  • Tampico, Mexico
  • Carolina, Puerto Rico
  • Ponce, Puerto Rico
  • San Juan, Puerto Rico
  • Trujillo Alto, Puerto Rico
  • Bacau, Romania
  • Brasov, Romania
  • Bucharest, Romania
  • Bucuresti, Romania
  • Oradea, Romania
  • Tg Mures, Romania
  • Arkhangelsk, Russian Federation
  • Barnaul, Russian Federation
  • Chelyabinsk, Russian Federation
  • Kemerovo, Russian Federation
  • Moscow, Russian Federation
  • Penza, Russian Federation
  • Rostov-On-Don, Russian Federation

Showing the first 100 of 137 sites across 13 countries.

09

References and documents

Publications

  • Rosenstock J, Chuck L, Gonzalez-Ortiz M, Merton K, Craig J, Capuano G, Qiu R. Initial Combination Therapy With Canagliflozin Plus Metformin Versus Each Component as Monotherapy for Drug-Naive Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):353-62. doi: 10.2337/dc15-1736. Epub 2016 Jan 19. PubMed 26786577 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01809327
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Mar 12, 2013
Start date
Jun 4, 2013
Primary completion
Dec 2, 2014
Completion
Dec 2, 2014
Results posted
Jan 6, 2016
Last update
Jul 11, 2017

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Janssen Research & Development, LLC

Start the discussion