Mechanisms of Weight Loss With SGLT2 Inhibition

Beth Israel Lahey Health

Status and phase: Completed; Phase 4

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Drug: Canagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02360774

2014P000335

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Canagliflozin

Experimental group

Description:

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

Treatment:

Drug: Canagliflozin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo