NCT02360774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Feb 2015

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2 days until next milestone

Results Posted

Study results publicly available

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

February 4, 2015

Results QC Date

June 27, 2018

Last Update Submit

August 2, 2018

Conditions

Type 2 DiabetesOverweightObesity

Keywords

CanagliflozinObesityWeight LossBody WeightBody Weight ChangesOverweightSodium-glucose transporter subtype 2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery

    18 weeks (duration of study)

  • Change in Body Composition, Measured Using DXA Scanning.

    18 weeks (duration of study)

  • Change in Glycemic Control

    18 weeks (duration of study)

Study Arms (2)

Canagliflozin

EXPERIMENTAL

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

Drug: Canagliflozin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CanagliflozinDRUG

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

Also known as: Invokana
Canagliflozin
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • BMI 25-45 kg/m2
  • Hemoglobin A1C \> 6.5% but \< 9%
  • Normal renal function (GFR \> 60)
  • Age 18-75

You may not qualify if:

  • Type 1 diabetes
  • History of recurrent UTI or mycotic genital infections
  • Treatment with insulin or a GLP1 agent
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityWeight LossBody WeightBody Weight Changes

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Jody Dushay
Organization
Beth Israel Deaconess Medical Center
jdushay@bidmc.harvard.edu
6176671996

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 11, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 3, 2018

Results First Posted

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)