Mechanisms of Weight Loss With SGLT2 Inhibition
Primary Purpose
Type 2 Diabetes, Overweight, Obesity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Canagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Canagliflozin, Obesity, Weight Loss, Body Weight, Body Weight Changes, Overweight, Sodium-glucose transporter subtype 2 inhibitor
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- BMI 25-45 kg/m2
- Hemoglobin A1C > 6.5% but < 9%
- Normal renal function (GFR > 60)
- Age 18-75
Exclusion Criteria:
- Type 1 diabetes
- History of recurrent UTI or mycotic genital infections
- Treatment with insulin or a GLP1 agent
- Pregnant or breastfeeding
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Canagliflozin
Placebo
Arm Description
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in Body Composition, Measured Using DXA Scanning.
Body composition will be measured at baseline and at study completion using DXA scanning.
Change in Glycemic Control
Hemoglobin A1C will be measured at baseline and at study completion.
Full Information
NCT ID
NCT02360774
First Posted
February 4, 2015
Last Updated
August 2, 2018
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02360774
Brief Title
Mechanisms of Weight Loss With SGLT2 Inhibition
Official Title
Mechanisms of Weight Loss With SGLT2 Inhibition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Janssen Scientific Affairs, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Overweight, Obesity
Keywords
Canagliflozin, Obesity, Weight Loss, Body Weight, Body Weight Changes, Overweight, Sodium-glucose transporter subtype 2 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canagliflozin
Arm Type
Experimental
Arm Description
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
Invokana
Intervention Description
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
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.
Time Frame
18 weeks (duration of study)
Secondary Outcome Measure Information:
Title
Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
Description
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.
Time Frame
18 weeks (duration of study)
Title
Change in Body Composition, Measured Using DXA Scanning.
Description
Body composition will be measured at baseline and at study completion using DXA scanning.
Time Frame
18 weeks (duration of study)
Title
Change in Glycemic Control
Description
Hemoglobin A1C will be measured at baseline and at study completion.
Time Frame
18 weeks (duration of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
BMI 25-45 kg/m2
Hemoglobin A1C > 6.5% but < 9%
Normal renal function (GFR > 60)
Age 18-75
Exclusion Criteria:
Type 1 diabetes
History of recurrent UTI or mycotic genital infections
Treatment with insulin or a GLP1 agent
Pregnant or breastfeeding
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanisms of Weight Loss With SGLT2 Inhibition
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