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Diabetes Mellitus, Type 2Phase 3NCT01809327

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 study testing Canagliflozin 100 mg, Canagliflozin 300 mg and Metformin XR in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 129 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin 100 mg, Canagliflozin 300 mg and Metformin XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,186 participants
Where
129 sitesin 13 countries
Study dates
4 Jun 2013to 2 Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

129 sites in 13 countries.

129 sites in 13 countries

United States52 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Austin, Texas

  • Study site

    Bellaire, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Bountiful, Utah

  • Study site

    Dallas, Texas

  • Study site

    Danville, Virginia

  • Study site

    Denver, Colorado

  • Study site

    Encinitas, California

  • Study site

    Evansville, Indiana

  • Study site

    Fleetwood, Pennsylvania

  • Study site

    Flint, Michigan

  • Study site

    Franklin, Ohio

  • Study site

    Hialeah, Florida

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Mandeville, Louisiana

  • Study site

    Mason, Ohio

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Mooresville, North Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New Port Richey, Florida

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    Norristown, Pennsylvania

  • Study site

    Northglenn, Colorado

  • Study site

    Northridge, California

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Opa-locka, Florida

  • Study site

    Pearland, Texas

  • Study site

    Perry, Georgia

  • Study site

    Perrysburg, Ohio

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Rancho Cucamonga, California

  • Study site

    Rapid City, South Dakota

  • Study site

    Richmond, Virginia

  • Study site

    Royal Oak, Michigan

  • Study site

    Salt Lake City, Utah

  • Study site

    Sunset, Louisiana

  • Study site

    Troy, Michigan

  • Study site

    Tualatin, Oregon

  • Study site

    Walnut Creek, California

  • Study site

    West Seneca, New York

  • Study site

    Yukon, Oklahoma

  • Study site

    Zanesville, Ohio

Other trials in United States

Russia15 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Chelyabinsk

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Penza

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Syktyvkar

  • Study site

    Tomsk

  • Study site

    Tyumen

  • Study site

    Voronezh

Other trials in Russia

Ukraine12 sites

  • Study site

    Cherkasy

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina7 sites

  • Study site

    Buenos Aires

  • Study site

    Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba

  • Study site

    Mar del Plata

  • Study site

    Morón

  • Study site

    Rosario

  • Study site

    Zárate

Other trials in Argentina

Mexico7 sites

  • Study site

    Celaya

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    México

  • Study site

    Monterrey

  • Study site

    Pachuca

  • Study site

    Tampico

Other trials in Mexico

Slovakia7 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Malacky

  • Study site

    Prešov

  • Study site

    Rimavská Sobota

  • Study site

    Šahy

  • Study site

    Trebišov

Other trials in Slovakia

South Africa6 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Halfway

  • Study site

    Johannesburg

  • Study site

    Soweto, Johannesburg

  • Study site

    Worcester

Other trials in South Africa

Hungary5 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Eger

  • Study site

    Szikszó

  • Study site

    Zalaegerszeg

Other trials in Hungary

Romania5 sites

  • Study site

    Bacau

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Oradea

  • Study site

    Tg Mures

Other trials in Romania

Czechia4 sites

  • Study site

    Kroměříž

  • Study site

    Pardubice

  • Study site

    Prague

  • Study site

    Uničov

Other trials in Czechia

Puerto Rico4 sites

  • Study site

    Carolina

  • Study site

    Ponce

  • Study site

    San Juan

  • Study site

    Trujillo Alto

Other trials in Puerto Rico

South Korea3 sites

  • Study site

    Goyang-si

  • Study site

    Seoul

  • Study site

    Suwon

Other trials in South Korea

Brazil2 sites

  • Study site

    Passo Fundo

  • Study site

    São Paulo

Other trials in Brazil

About this study

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

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.

Being tested
Canagliflozin 100 mg, Canagliflozin 300 mg, Metformin XR
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Canagliflozin (JNJ-28431754), Metformin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Canagliflozin 100 mgDrug

    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).

  • Canagliflozin 300 mgDrug

    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).

  • Metformin XRDrug

    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.

Study groups in NCT01809327
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalParticipants 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.
Receives: Drug: Canagliflozin 100 mg
Canagliflozin 300 mgExperimentalParticipants 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.
Receives: Drug: Canagliflozin 300 mg
Metformin XRExperimentalParticipants 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.
Receives: Drug: Metformin XR
Canagliflozin 100 mg + Metformin XRExperimentalParticipants 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.
Receives: Drug: Canagliflozin 100 mg; Drug: Metformin XR
Canagliflozin 300 mg + Metformin XRExperimentalParticipants 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.
Receives: Drug: Canagliflozin 300 mg; Drug: Metformin XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 (Baseline) and Week 26

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 30 weeks of last study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2013 (estimated)
  2. Study start4 Jun 2013
  3. Primary completion2 Dec 2014
  4. Study completion2 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809327
Sponsor's protocol ID
CR100034
Other IDs
28431754DIA3011, 2011-000400-17
Status last verified
Jun 2017
First submitted
8 Mar 2013
Last updated
11 Jul 2017
Data monitoring committee
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin 100 mg, Canagliflozin 300 mg and Metformin XR in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 129 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Russia, Ukraine, Argentina, Mexico and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 (time frame: Day 1 (Baseline) and Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809327, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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