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

June 12, 2017 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • 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
  • Brazil
      • Passo Fundo, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Czechia
      • Kromeriz, Czechia
      • Pardubice, Czechia
      • Praha, Czechia
      • Praha 8, Czechia
      • Unicov, Czechia
  • Hungary
      • Balatonfured, Hungary
      • Budapest, Hungary
      • Eger, Hungary
      • Szikszó, Hungary
      • Zalaegerszeg, Hungary
  • Korea, Republic of
      • Goyang-Si, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
  • Mexico
      • Celaya, Mexico
      • Durango, Mexico
      • Guadalajara, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico
      • Pachuca De Soto, Mexico
      • Tampico, Mexico
  • Puerto Rico
      • Carolina, Puerto Rico
      • Ponce, Puerto Rico
      • San Juan, Puerto Rico
      • Trujillo Alto, Puerto Rico
  • Romania
      • Bacau, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Oradea, Romania
      • Tg Mures, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Barnaul, Russian Federation
      • Chelyabinsk, Russian Federation
      • Kemerovo, Russian Federation
      • Moscow, Russian Federation
      • Penza, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • Syktyvkar, Russian Federation
      • Tomsk, Russian Federation
      • Tyumen, Russian Federation
      • Voronezh, Russian Federation
  • Slovakia
      • Banska Bystrica, Slovakia
      • Bratislava, Slovakia
      • Malacky, Slovakia
      • Presov, Slovakia
      • Rimavska Sobota, Slovakia
      • Sahy, Slovakia
      • Trebisov, Slovakia
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Halfway, South Africa
      • Johannesburg, South Africa
      • Johannesburg N/A, South Africa
      • Soweto, Johannesburg, South Africa
      • Worcester, South Africa
  • Ukraine
      • Cherkasy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano Frankivsk, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Odesa, Ukraine
      • Poltava, Ukraine
      • Sumy, Ukraine
      • Zaporozhye, Ukraine
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • 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
    • Colorado
      • Denver, Colorado, United States
      • Northglenn, Colorado, United States
    • Florida
      • Hialeah, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Opa-locka, Florida, United States
    • Georgia
      • Perry, Georgia, United States
    • Indiana
      • Evansville, Indiana, United States
    • Louisiana
      • Mandeville, Louisiana, United States
      • Metairie, Louisiana, United States
      • Sunset, Louisiana, United States
    • Michigan
      • Flint, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Royal Oak, Michigan, United States
      • Troy, Michigan, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
      • Picayune, Mississippi, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • West Seneca, New York, United States
    • North Carolina
      • Hickory, North Carolina, United States
      • Mooresville, North Carolina, United States
    • Ohio
      • Franklin, Ohio, United States
      • Mason, Ohio, United States
      • Perrysburg, Ohio, United States
      • Zanesville, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Yukon, Oklahoma, United States
    • Oregon
      • Tualatin, Oregon, United States
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Bellaire, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Pearland, Texas, United States
      • Plano, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Danville, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Baseline) and Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Baseline) and Week 26
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.
Week 26
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.
Day 1 (Baseline) and Week 26
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.
Day 1 (Baseline) and Week 26
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.
Day 1 (Baseline) and Week 26
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.
Up to 30 weeks of last study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100034
  • 28431754DIA3011 (Other Identifier: Janssen Research & Development, LLC)
  • 2011-000400-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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