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Diabetes Mellitus, Type IIPhase 2NCT00642278

An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

A Phase 2 study testing Canagliflozin (JNJ-28431754) and Sitagliptin in people with Diabetes Mellitus, Type II and Diabetes Mellitus, Non Insulin Dependent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 78 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 evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Canagliflozin (JNJ-28431754) and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
78 sitesin 13 countries
Study dates
Apr 2008to Jan 2009
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of type 2 diabetes mellitus
  • Hemoglobin A1c levels >=7% and <=10.5%
  • taking a stable daily dose of metformin
  • Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
  • Stable body weight
  • Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women

Who cannot join

  • Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
  • Known contraindication or suspected hypersensitivity to sitagliptin or metformin
  • A history of diabetic ketoacidosis or type 1 diabetes mellitus
  • History of pancreas or beta-cell transplantation
  • History of active proliferative diabetic retinopathy
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Trial locations and contacts

78 sites in 13 countries.

78 sites in 13 countries

United States30 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Encinitas, California

  • Study site

    Golden, Colorado

  • Study site

    Greer, South Carolina

  • Study site

    Haverhill, Massachusetts

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Lincoln, California

  • Study site

    Los Angeles, California

  • Study site

    Merced, California

  • Study site

    Mesa, Arizona

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nampa, Idaho

  • Study site

    New Braunfels, Texas

  • Study site

    New Hyde Park, New York

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Portland, Oregon

  • Study site

    Roseville, California

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Topeka, Kansas

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

Other trials in United States

Canada8 sites

  • Study site

    Brampton, Ontario

  • Study site

    Chilliwack, British Columbia

  • Study site

    Coquitlam, British Columbia

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Saint Romuald, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

Other trials in Canada

Poland8 sites

  • Study site

    Bydgoszcz

  • Study site

    Gdansk

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Romania6 sites

  • Study site

    Baia Mare

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Galati

  • Study site

    Ploieşti

Other trials in Romania

India4 sites

  • Study site

    Bangalore

  • Study site

    Hyderabad

  • Study site

    Nagpur

  • Study site

    Pune

Other trials in India

Mexico4 sites

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Monterrey

  • Study site

    Zapopan

Other trials in Mexico

United Kingdom4 sites

  • Study site

    Belfast

  • Study site

    Bolton

  • Study site

    Exeter

  • Study site

    Lincoln

Other trials in United Kingdom

Czechia3 sites

  • Study site

    Olomouc

  • Study site

    Písek

  • Study site

    Prague

Other trials in Czechia

Russia3 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

Other trials in Russia

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    Bueos Aires

Other trials in Argentina

Bulgaria2 sites

  • Study site

    Pleven

  • Study site

    Sofia

Other trials in Bulgaria

Malaysia2 sites

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

Other trials in Malaysia

Puerto Rico2 sites

  • Study site

    Ponce Pr

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Read the detailed description

Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).

Being tested
Canagliflozin (JNJ-28431754), Sitagliptin, Placebo
Keywords
Type 2 diabetes mellitus, Metformin, Hemoglobin A1c
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Canagliflozin (JNJ-28431754)Drug

    Also called JNJ-28431754

    One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.

  • SitagliptinDrug

    One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

  • PlaceboDrug

    One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.

Study groups in NCT00642278
Study groupRoleWhat they receive
Canagliflozin 50 mg dailyExperimentalEach patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo
Canagliflozin 100 mg dailyExperimentalEach patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo
Canagliflozin 200 mg dailyExperimentalEach patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo
Canagliflozin 300 mg dailyExperimentalEach patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening).
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Placebo
Canagliflozin 300 mg twice dailyExperimentalEach patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
Receives: Drug: Canagliflozin (JNJ-28431754)
Sitagliptin 100 mg dailyActive comparatorEach patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Receives: Drug: Sitagliptin; Drug: Placebo
PlaceboPlacebo comparatorEach patient will receive matching placebo twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change in HbA1c From Baseline to Week 12

    The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

    Measured: Day 1 (Baseline) and Week 12

Secondary outcomes (5)

  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12

    The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

    Measured: Day 1 (Baseline) and Week 12

  2. Percentage of Patients With Symptoms of Hypoglycemia

    The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.

    Measured: Up to Week 12

  3. Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12

    The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

    Measured: Day 1 (Baseline) and Week 12

  4. Absolute Change in Body Weight From Baseline to Week 12

    The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.

    Measured: Day 1 (Baseline) and Week 12

  5. Percent Change in Body Weight From Baseline to Week 12

    The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

    Measured: Day 1 (Baseline) and Week 12

Timeline

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

  1. First posted25 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2009
  4. Study completionJan 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00642278
Sponsor's protocol ID
CR014587
Other IDs
28431754DIA2001
Status last verified
Jul 2013
First submitted
21 Mar 2008
Last updated
19 Jul 2013
Data monitoring committee
No

Publications

  • Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012 Jul;28(7):1173-8. doi: 10.1185/03007995.2012.697053. Epub 2012 Jun 14.

    PubMed 22632452

  • Nicolle LE, Capuano G, Ways K, Usiskin K. Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. Curr Med Res Opin. 2012 Jul;28(7):1167-71. doi: 10.1185/03007995.2012.689956. Epub 2012 May 15.

    PubMed 22548646

  • Rosenstock J, Aggarwal N, Polidori D, Zhao Y, Arbit D, Usiskin K, Capuano G, Canovatchel W; Canagliflozin DIA 2001 Study Group. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care. 2012 Jun;35(6):1232-8. doi: 10.2337/dc11-1926. Epub 2012 Apr 9.

    PubMed 22492586

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canagliflozin (JNJ-28431754) and Sitagliptin in people with Diabetes Mellitus, Type II and Diabetes Mellitus, Non Insulin Dependent, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 78 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 6 inclusion and 6 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Canada, Poland, Romania, India 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 May 2013). 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 HbA1c From Baseline to Week 12 (time frame: Day 1 (Baseline) and Week 12). 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 NCT00642278, which also lists 3 linked publications.

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 19 Jul 2013.

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