Mechanisms of Weight Loss With SGLT2 Inhibition

Obesity Clinical Trial

Official title:

Mechanisms of Weight Loss With SGLT2 Inhibition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360774
• Other study ID #: 2014P000335
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Type 2 Diabetes
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 weeks (duration of study)
Secondary	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.	18 weeks (duration of study)
Secondary	Change in Body Composition, Measured Using DXA Scanning.	Body composition will be measured at baseline and at study completion using DXA scanning.	18 weeks (duration of study)
Secondary	Change in Glycemic Control	Hemoglobin A1C will be measured at baseline and at study completion.	18 weeks (duration of study)