Mechanisms of Weight Loss With SGLT2 Inhibition

Phase 4

Completed

• Conditions: Type 2 Diabetes; Overweight; Obesity
• Interventions: Drug: Canagliflozin; Drug: Placebo

• Registration Number: NCT02360774
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Results First Submitted: 2018-06-27
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Results First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin	Canagliflozin	Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.
Placebo	Placebo	Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	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

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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States