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Diabetes Mellitus, Type 2Phase 3NCT01106651

A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

A Phase 3 study testing Canagliflozin 100 mg, Canagliflozin 300 mg and Antihyperglycemic agent(s) in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 86 sites in 17 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin 100 mg, Canagliflozin 300 mg and Antihyperglycemic agent(s)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
716 participants
Where
86 sitesin 17 countries
Study dates
Jun 2010to May 2013
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 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
  • Patients in the study must have a HbA1c between >=7 and <=10.0%
  • Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

Who cannot join

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Trial locations and contacts

86 sites in 17 countries.

86 sites in 17 countries

United States34 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Bismarck, North Dakota

  • Study site

    Bristol, Tennessee

  • Study site

    Carmichael, California

  • Study site

    Carrollton, Texas

  • Study site

    Cary, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Citrus Heights, California

  • Study site

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Fair Oaks, California

  • Study site

    Fleming Island, Florida

  • Study site

    Franklin, Ohio

  • Study site

    Glendale, Arizona

  • Study site

    Irving, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Miami, Florida

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Pahrump, Nevada

  • Study site

    Phoenix, Arizona

  • Study site

    Plano, Texas

  • Study site

    Renton, Washington

  • Study site

    Richardson, Texas

  • Study site

    Roseville, California

  • Study site

    Sacramento, California

  • Study site

    San Diego, California

  • Study site

    Tacoma, Washington

  • Study site

    Walnut Creek, California

  • Study site

    Waltham, Massachusetts

  • Study site

    Wenatchee, Washington

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

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Canada8 sites

  • Study site

    Barrie, Ontario

  • Study site

    London, Ontario

  • Study site

    Markham, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Oakville, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

United Kingdom7 sites

  • Study site

    Birmingham

  • Study site

    Cardiff

  • Study site

    Glasgow

  • Study site

    Liverpool

  • Study site

    Manchester

  • Study site

    Reading

  • Study site

    Salford

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Poland5 sites

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Australia4 sites

  • Study site

    Fremantle

  • Study site

    Heidelberg Heights

  • Study site

    Meadowbrook

  • Study site

    Richmond

Other trials in Australia

New Zealand4 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Spain4 sites

  • Study site

    Granada

  • Study site

    Madrid

  • Study site

    Pozuelo de Alarcón

  • Study site

    Seville

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France3 sites

  • Study site

    Corbeil-Essonnes

  • Study site

    Paris

  • Study site

    Vénissieux

Other trials in France

India3 sites

  • Study site

    Bangalore

  • Study site

    Nagpur

  • Study site

    Pune

Other trials in India

Colombia2 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

Other trials in Colombia

Greece2 sites

  • Study site

    Thessaloniki

  • Study site

    Thessalonikis

Other trials in Greece

Romania2 sites

  • Study site

    Bucharest

  • Study site

    Sibiu

Other trials in Romania

Sweden2 sites

  • Study site

    Gothenburg

  • Study site

    Uppsala

Other trials in Sweden

Switzerland2 sites

  • Study site

    Bruderholz

  • Study site

    Sankt Gallen

Other trials in Switzerland

Ukraine2 sites

  • Study site

    Kharkiv

  • Study site

    Kiev

Other trials in Ukraine

Hong Kong1 site

  • Study site

    Shatin

Other trials in Hong Kong

South Africa1 site

  • Study site

    Pretoria

Other trials in South Africa

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

Read the detailed description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy to control their diabetes. Approximately 720 older (55 to 80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of double-blind treatment followed by a 78-week extension period). In addition, all patients will take stable doses of the antihyperglycemic agent(s) that they were taking before entry in the study for the duration of the study. Patients will participate in the study for approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with an antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, measures of bone health, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double blind canagliflozin (100 mg or 300 mg) or matching placebo for 104 weeks.

Being tested
Canagliflozin 100 mg, Canagliflozin 300 mg, Antihyperglycemic agent(s), Placebo
Keywords
Canagliflozin, Placebo, Hemoglobin A1c, Bone, Type 2 diabetes mellitus
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 100 mgDrug

    One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

  • Canagliflozin 300 mgDrug

    One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

  • Antihyperglycemic agent(s)Drug

    Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.

  • PlaceboDrug

    One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Study groups in NCT01106651
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Receives: Drug: Canagliflozin 100 mg; Drug: Antihyperglycemic agent(s)
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Receives: Drug: Canagliflozin 300 mg; Drug: Antihyperglycemic agent(s)
PlaceboPlacebo comparatorEach patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Receives: Drug: Antihyperglycemic agent(s); 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 26

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

Secondary outcomes (13)

  1. Percentage of Patients With HbA1c <7% at Week 26

    The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

    Measured: Week 26

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

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

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  4. Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

    The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  5. Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

    Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  6. Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

    Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  7. Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  8. Percent Change in Triglycerides From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  9. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  10. Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  11. Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  12. Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  13. Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

Timeline

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

  1. First posted20 Apr 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2011
  4. Study completionMay 2013

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106651
Sponsor's protocol ID
CR017014
Other IDs
28431754DIA3010
Status last verified
Oct 2014
First submitted
1 Apr 2010
Last updated
4 Nov 2014
Data monitoring committee
Yes

Publications

  • Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.

    PubMed 28619659

  • Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

    PubMed 27977934

  • Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

    PubMed 27002421

  • Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

    PubMed 26580237

  • Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.

    PubMed 26580234

  • Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

    PubMed 24786834

  • Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

    PubMed 24517339

  • Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.

    PubMed 23680739

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin 100 mg, Canagliflozin 300 mg and Antihyperglycemic agent(s) in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 86 sites in 17 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 3 inclusion and 1 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, United Kingdom, Poland, Australia and 12 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 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 29 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 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 NCT01106651, which also lists 8 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 4 Nov 2014.

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