Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanisms of Weight Loss With SGLT2 Inhibition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02360774
Recruitment Status : Completed
First Posted : February 11, 2015
Results First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Jody Dushay, Beth Israel Deaconess Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Overweight Obesity Drug: Canagliflozin Drug: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms of Weight Loss With SGLT2 Inhibition
Study Start Date : February 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Glycemic Control [ Time Frame: 18 weeks (duration of study) ]
    Hemoglobin A1C will be measured at baseline and at study completion.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360774


Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Janssen Scientific Affairs, LLC
  Study Documents (Full-Text)

Documents provided by Jody Dushay, Beth Israel Deaconess Medical Center:
Informed Consent Form  [PDF] October 10, 2017
Study Protocol and Statistical Analysis Plan  [PDF] July 12, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jody Dushay, Principle Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02360774    
Other Study ID Numbers: 2014P000335
First Posted: February 11, 2015    Key Record Dates
Results First Posted: August 3, 2018
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jody Dushay, Beth Israel Deaconess Medical Center:
Canagliflozin
Obesity
Weight Loss
Body Weight
 Body Weight Changes
Overweight
Sodium-glucose transporter subtype 2 inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Weight Loss
Body Weight
Body Weight Changes
Canagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs