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Diabetes Mellitus, Type 2Phase 2NCT01340664

An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

A Phase 2 study testing Canagliflozin 50 mg, Canagliflozin 150 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 61 sites in 7 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 patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin 50 mg, Canagliflozin 150 mg and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
61 sitesin 7 countries
Study dates
Jul 2011to Apr 2012
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 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 be currently treated with metformin
  • Patients in the study must have a HbA1c between >=7 and <=10.5%
  • 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, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Trial locations and contacts

61 sites in 7 countries.

61 sites in 7 countries

United States26 sites

  • Study site

    Avon, Indiana

  • Study site

    Bountiful, Utah

  • Study site

    Bradenton, Florida

  • Study site

    Charlotte, North Carolina

  • Study site

    Columbus, Ohio

  • Study site

    East Providence, Rhode Island

  • Study site

    Houston, Texas

  • Study site

    Little Rock, Arkansas

  • Study site

    Madisonville, Kentucky

  • Study site

    Marianna, Florida

  • Study site

    Mason, Ohio

  • Study site

    Metairie, Louisiana

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    National City, California

  • Study site

    Oregon City, Oregon

  • Study site

    Pearland, Texas

  • Study site

    Perrysburg, Ohio

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    San Antonio, Texas

  • Study site

    Savannah, Georgia

  • Study site

    Spring Valley, California

  • Study site

    Tulsa, Oklahoma

  • Study site

    Valparaiso, Indiana

  • Study site

    Virginia Beach, Virginia

  • Study site

    Yukon, Oklahoma

Other trials in United States

Czechia7 sites

  • Study site

    Beroun

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Pardubice

  • Study site

    Písek

  • Study site

    Prague

  • Study site

    Znojmo

Other trials in Czechia

Russia7 sites

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Tyumen

  • Study site

    Voronezh

Other trials in Russia

Romania6 sites

  • Study site

    Bacau

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Galati

  • Study site

    Târgu Mureş

Other trials in Romania

Slovakia6 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Košice

  • Study site

    Prešov

  • Study site

    Šahy

  • Study site

    Trebišov

Other trials in Slovakia

Canada5 sites

  • Study site

    Brampton, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

Other trials in Canada

Mexico4 sites

  • Study site

    Aguascalientes

  • Study site

    Guadalajara, Jalisco.

  • Study site

    Monterrey

  • Study site

    Tampico

Other trials in Mexico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Read the detailed description

This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Being tested
Canagliflozin 50 mg, Placebo, Canagliflozin 150 mg, Metformin
Keywords
Canagliflozin, Placebo, Metformin, Hemoglobin A1c, 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 50 mgDrug

    One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks

  • PlaceboDrug

    1 placebo capsule taken orally twice daily with a meal for 18 weeks

  • Canagliflozin 150 mgDrug

    1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks

  • MetforminDrug

    The patient's stable daily dose of Metformin background therapy should be continued throughout the study.

Study groups in NCT01340664
Study groupRoleWhat they receive
Canagliflozin 50 mg bidExperimentalEach patient will receive 50 mg canagliflozin twice daily for 18 weeks.
Receives: Drug: Canagliflozin 50 mg; Drug: Metformin
Canagliflozin 150 mg bidExperimentalEach patient will receive 150 mg canagliflozin twice daily for 18 weeks
Receives: Drug: Canagliflozin 150 mg; Drug: Metformin
PlaceboPlacebo comparatorEach patient will receive matching placebo twice daily for 18 weeks
Receives: Drug: Placebo; Drug: Metformin

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 18

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 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 18

Secondary outcomes (3)

  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 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 18

  2. Percent Change in Body Weight From Baseline to Week 18

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 18

  3. Percentage of Patients With HbA1c <7% at Week 18

    The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

    Measured: Week 18

Timeline

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

  1. First posted22 Apr 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

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
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340664
Sponsor's protocol ID
CR017914
Other IDs
28431754DIA2003, 2010-024256-28
Status last verified
Sep 2014
First submitted
21 Apr 2011
Last updated
16 Sep 2014
Data monitoring committee
Yes

Publications

  • Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014 May 5;1(2):54-60. doi: 10.1016/j.jcte.2014.04.001. eCollection 2014 Jun.

    PubMed 29159083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canagliflozin 50 mg, Canagliflozin 150 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 61 sites in 7 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 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Czechia, Russia, Romania, Slovakia and 2 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 1 Sep 2014). 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 18 (time frame: Day 1 (Baseline) and Week 18). 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 NCT01340664, 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 16 Sep 2014.

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