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
3 other identifiers
interventional
1,186
13 countries
129
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jun 2013
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedStudy Start
First participant enrolled
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2014
CompletedResults Posted
Study results publicly available
January 6, 2016
CompletedJuly 11, 2017
June 1, 2017
1.5 years
March 8, 2013
December 1, 2015
June 12, 2017
Conditions
Keywords
Outcome Measures
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.
Day 1 (Baseline) and Week 26
Secondary Outcomes (6)
Percent Change in Body Weight From Baseline to Week 26
Day 1 (Baseline) and Week 26
Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26
Week 26
Change in Systolic Blood Pressure From Baseline at Week 26
Day 1 (Baseline) and Week 26
Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Day 1 (Baseline) and Week 26
Percent Change in Triglycerides From Baseline to Week 26
Day 1 (Baseline) and Week 26
- +1 more secondary outcomes
Study Arms (5)
Canagliflozin 100 mg
EXPERIMENTALParticipants 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.
Canagliflozin 300 mg
EXPERIMENTALParticipants 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.
Metformin XR
EXPERIMENTALParticipants 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.
Canagliflozin 100 mg + Metformin XR
EXPERIMENTALParticipants 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.
Canagliflozin 300 mg + Metformin XR
EXPERIMENTALParticipants 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
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).
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Encinitas, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Norwalk, California, United States
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Rancho Cucamonga, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Northglenn, Colorado, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Opa-locka, Florida, United States
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Perry, Georgia, United States
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Evansville, Indiana, United States
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Mandeville, Louisiana, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Royal Oak, Michigan, United States
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Troy, Michigan, United States
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Olive Branch, Mississippi, United States
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Picayune, Mississippi, United States
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Albuquerque, New Mexico, United States
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West Seneca, New York, United States
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Hickory, North Carolina, United States
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Mooresville, North Carolina, United States
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Franklin, Ohio, United States
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Mason, Ohio, United States
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Perrysburg, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Yukon, Oklahoma, United States
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Tualatin, Oregon, United States
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Fleetwood, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Pearland, Texas, United States
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Plano, Texas, United States
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Bountiful, Utah, United States
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Salt Lake City, Utah, United States
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Danville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Morón, Argentina
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Rosario, Argentina
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Zárate, Argentina
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Passo Fundo, Brazil
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São Paulo, Brazil
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Kroměříž, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Uničov, Czechia
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Balatonfüred, Hungary
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Budapest, Hungary
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Eger, Hungary
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Szikszó, Hungary
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Zalaegerszeg, Hungary
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Celaya, Mexico
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Durango, Mexico
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Guadalajara, Mexico
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México, Mexico
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Monterrey, Mexico
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Pachuca, Mexico
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Tampico, Mexico
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Carolina, Puerto Rico
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Ponce, Puerto Rico
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San Juan, Puerto Rico
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Trujillo Alto, Puerto Rico
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Bacau, Romania
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Brasov, Romania
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Bucharest, Romania
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Oradea, Romania
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Tg Mures, Romania
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Arkhangelsk, Russia
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Barnaul, Russia
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Chelyabinsk, Russia
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Kemerovo, Russia
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Moscow, Russia
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Penza, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Smolensk, Russia
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Syktyvkar, Russia
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Tomsk, Russia
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Tyumen, Russia
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Voronezh, Russia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Malacky, Slovakia
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Prešov, Slovakia
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Rimavská Sobota, Slovakia
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Šahy, Slovakia
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Trebišov, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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Halfway, South Africa
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Johannesburg, South Africa
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Soweto, Johannesburg, South Africa
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Worcester, South Africa
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Goyang-si, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Cherkasy, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (1)
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.
PMID: 26786577DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Research
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 12, 2013
Study Start
June 4, 2013
Primary Completion
December 2, 2014
Study Completion
December 2, 2014
Last Updated
July 11, 2017
Results First Posted
January 6, 2016
Record last verified: 2017-06