Mechanisms of Weight Loss With SGLT2 Inhibition

August 2, 2018 updated by: Jody Dushay, Beth Israel Deaconess Medical Center

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Drug: Canagliflozin
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Other Names:
  • Invokana
Placebo Comparator: Placebo
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Drug: Placebo
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 weeks (duration of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
Time Frame: 18 weeks (duration of study)
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.
18 weeks (duration of study)
Change in Body Composition, Measured Using DXA Scanning.
Time Frame: 18 weeks (duration of study)
Body composition will be measured at baseline and at study completion using DXA scanning.
18 weeks (duration of study)
Change in Glycemic Control
Time Frame: 18 weeks (duration of study)
Hemoglobin A1C will be measured at baseline and at study completion.
18 weeks (duration of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P000335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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