Diabetes Mellitus, Type 2Phase 3NCT01381900

A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

A Phase 3 study testing Canagliflozin 100mg, Canagliflozin 300mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 25 sites in 3 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 assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea. 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 100mg, Canagliflozin 300mg and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 678 participants
Where: 25 sitesin 3 countries
Study dates: Aug 2011to Nov 2012
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study.

Who cannot join

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
History of a severe hypoglycemic episode within 6 months before screening
History of or current illness considered to be clinically significant by the investigator

Trial locations and contacts

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

China20 sites

Study site
Baotou
Study site
Beijing
Study site
Changchun
Study site
Changsha
Study site
Chengdu
Study site
Chongqing
Study site
Guangzhou
Study site
Hangzhou
Study site
Harbin
Study site
Nanchang
Study site
Nanjing
Study site
Nanning
Study site
Shanghai
Study site
Shenyang
Study site
Shiyan
Study site
Siping
Study site
Suzhou
Study site
Tianjin
Study site
Wuxi
Study site
Xi'an

Other trials in China

Malaysia3 sites

Study site
Kota Bharu
Study site
Kuala Selangor
Study site
Pulau Pinang

Other trials in Malaysia

Vietnam2 sites

Study site
Hanoi
Study site
Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea

Read the detailed description

This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, Canagliflozin 100mg, Canagliflozin 300mg, Metformin, Sulphonylurea
Keywords: Canagliflozin, Placebo, 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.

PlaceboDrug
Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Canagliflozin 100mgDrug
Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Canagliflozin 300mgDrug
Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
MetforminDrug
The participant's stable dose of background therapy of metformin should be continued throughout the study.
SulphonylureaDrug
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.

Study groups in NCT01381900
Study group	Role	What they receive
Canagliflozin 100mg	Experimental	Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. Receives: Drug: Canagliflozin 100mg; Drug: Metformin; Drug: Sulphonylurea
Canagliflozin 300mg	Experimental	Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. Receives: Drug: Canagliflozin 300mg; Drug: Metformin; Drug: Sulphonylurea
Placebo	Placebo comparator	Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. Receives: Drug: Placebo; Drug: Metformin; Drug: Sulphonylurea

What is being measured

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

Change in Glycosylated Hemoglobin (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 (4)

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
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
Percentage of Patients With Glycosylated Hemoglobin (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: Day 1 (Baseline) and Week 18
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Measured: Day 1 (Baseline) and Week 18

Timeline

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

Aug 2011Nov 2012

First posted27 Jun 2011 (estimated)
Study startAug 2011
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Care provider
Enrolment: 678 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01381900
Sponsor's protocol ID: CR018541
Other IDs: 28431754DIA3014
Status last verified: Apr 2014
First submitted: 23 Jun 2011
Last updated: 9 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea
ClinicalTrials.gov ID: NCT01381900
Acronym / sponsor ID: CR018541
Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin, Placebo, Type 2 diabetes mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 678 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 9 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Canagliflozin 100mg	Experimental	Drug: Canagliflozin 100mg, Drug: Metformin, Drug: SulphonylureaEach participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300mg	Experimental	Drug: Canagliflozin 300mg, Drug: Metformin, Drug: SulphonylureaEach participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Placebo	Placebo comparator	Drug: Placebo, Drug: Metformin, Drug: SulphonylureaEach participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study.

Key exclusion criteria (4 listed)

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
History of a severe hypoglycemic episode within 6 months before screening
History of or current illness considered to be clinically significant by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboForm=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).	Drug	Placebo
Canagliflozin 100mgType=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).	Drug	Canagliflozin 100mg
Canagliflozin 300mgType=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).	Drug	Canagliflozin 300mg
MetforminThe participant's stable dose of background therapy of metformin should be continued throughout the study.	Drug	Canagliflozin 100mg, Canagliflozin 300mg, Placebo
SulphonylureaThe participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.	Drug	Canagliflozin 100mg, Canagliflozin 300mg, Placebo

Primary outcome

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
Time frame: Day 1 (Baseline) and 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.

4 secondary outcomes

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
Time frame: Day 1 (Baseline) and Week 18
Percent Change in Body Weight From Baseline to Week 18
Time frame: Day 1 (Baseline) and Week 18
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18
Time frame: Day 1 (Baseline) and Week 18
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
Time frame: Day 1 (Baseline) and Week 18

Results and safety

Results posted to the registry on 9 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	226	217
Canagliflozin 100 mg	223	214
Canagliflozin 300 mg	227	215

Primary outcome: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18

Time frame: Day 1 (Baseline) and Week 18. Least squares mean (Standard Error). Unit: Percent

Measure	Placebo n = 226	Canagliflozin 100 mg n = 223	Canagliflozin 300 mg n = 227
Value	-0.47 (0.096)	-0.97 (0.095)	-1.06 (0.095)

Placebo vs Canagliflozin 100 mg: Least-Squares Mean Difference: -0.51 (95% CI -0.644 to -0.367), p <0.001, ANCOVA
Placebo vs Canagliflozin 300 mg: Least-Squares Mean Difference: -0.59 (95% CI -0.731 to -0.453), p <0.001, ANCOVA

Population analysed: Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 226 (1.8%)	22 of 226 (9.7%)	Not reported
Canagliflozin 100 mg	5 of 223 (2.2%)	27 of 223 (12.1%)	Not reported
Canagliflozin 300 mg	4 of 227 (1.8%)	27 of 227 (11.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin 100mg, Canagliflozin 300mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 25 sites in 3 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 1 inclusion and 4 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China, Malaysia, Vietnam. 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 9 Jan 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 Glycosylated Hemoglobin (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 NCT01381900.

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 9 May 2014.