Type 2 DiabetesPhase 4NCT02360774

Mechanisms of Weight Loss With SGLT2 Inhibition

A Phase 4 study testing Canagliflozin in people with Type 2 Diabetes and Overweight, run by Beth Israel Deaconess Medical Center at 1 site in United States.

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 investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes, Overweight, Obesity
What is being tested?: Canagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Aug 2018
Phase: Phase 4
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

Type 2 diabetes
BMI 25-45 kg/m2
Hemoglobin A1C > 6.5% but < 9%
Normal renal function (GFR > 60)
Age 18-75

Who cannot join

Type 1 diabetes
History of recurrent UTI or mycotic genital infections
Treatment with insulin or a GLP1 agent
Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.

The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.

Conditions: Type 2 Diabetes, Overweight, Obesity
Being tested: Canagliflozin, Placebo
Keywords: Canagliflozin, Obesity, Weight Loss, Body Weight, Body Weight Changes, Overweight, Sodium-glucose transporter subtype 2 inhibitor
Medical subject headings: Diabetes Mellitus, Type 2, Overweight, Obesity, Weight Loss, Body Weight, Body Weight Changes

What participants receive

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

CanagliflozinDrug
Also called Invokana
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
PlaceboDrug
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.

Study groups in NCT02360774
Study group	Role	What they receive
Canagliflozin	Experimental	Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Receives: Drug: Canagliflozin
Placebo	Placebo comparator	Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Receives: Drug: Placebo

What is being measured

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

Change in Body Weight
Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.
Measured: 18 weeks (duration of study)

Secondary outcomes (3)

Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study.
Measured: 18 weeks (duration of study)
Change in Body Composition, Measured Using DXA Scanning.
Body composition will be measured at baseline and at study completion using DXA scanning.
Measured: 18 weeks (duration of study)
Change in Glycemic Control
Hemoglobin A1C will be measured at baseline and at study completion.
Measured: 18 weeks (duration of study)

Timeline

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

Feb 2015Aug 2018

First posted11 Feb 2015 (estimated)
Study startFeb 2015
Primary completionAug 2018
Study completionAug 2018

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 Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Beth Israel Deaconess Medical CenterThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02360774
Sponsor's protocol ID: 2014P000335
Status last verified: Aug 2018
First submitted: 4 Feb 2015
Last updated: 3 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms of Weight Loss With SGLT2 Inhibition
ClinicalTrials.gov ID: NCT02360774
Acronym / sponsor ID: 2014P000335
Conditions: Type 2 Diabetes, Overweight, Obesity
Keywords: Canagliflozin, Obesity, Weight Loss, Body Weight, Body Weight Changes, Overweight, Sodium-glucose transporter subtype 2 inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Collaborators: Janssen Scientific Affairs, LLC
Study start: Feb 2015
Primary completion: Aug 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 11 Feb 2015 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

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

Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.

The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Canagliflozin	Experimental	Drug: CanagliflozinSubjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Placebo	Placebo comparator	Drug: PlaceboSubjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes
BMI 25-45 kg/m2
Hemoglobin A1C > 6.5% but < 9%
Normal renal function (GFR > 60)
Age 18-75

Key exclusion criteria (4 listed)

Type 1 diabetes
History of recurrent UTI or mycotic genital infections
Treatment with insulin or a GLP1 agent
Pregnant or breastfeeding

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
CanagliflozinAlso: InvokanaSubjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.	Drug	Canagliflozin
PlaceboSubjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.	Drug	Placebo

Primary outcome

Change in Body Weight
Time frame: 18 weeks (duration of study)
Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.

3 secondary outcomes

Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
Time frame: 18 weeks (duration of study)
Change in Body Composition, Measured Using DXA Scanning.
Time frame: 18 weeks (duration of study)
Change in Glycemic Control
Time frame: 18 weeks (duration of study)

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canagliflozin	15	12
Placebo	15	13

Primary outcome: Change in Body Weight

Time frame: 18 weeks (duration of study). Mean (Standard Error). Unit: kg

Measure	Canagliflozin n = 13	Placebo n = 12
Value	3.0 (0.7)	0.3 (0.9)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: duration of the study. each participant was enrolled for up to 18 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 12 (16.7%)	5 of 12 (41.7%)	0 of 12
Canagliflozin	1 of 13 (7.7%)	5 of 13 (38.5%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin in people with Type 2 Diabetes and Overweight, run by Beth Israel Deaconess Medical Center at 1 site in United States.

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 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 3 Aug 2018). 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 Body Weight (time frame: 18 weeks (duration of study)). 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 NCT02360774.

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 3 Aug 2018.