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Completed

NCT Number: NCT02360774

Mechanisms of Weight Loss With SGLT2 Inhibition

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin

Drug

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

Other names: Invokana

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2015
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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