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Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight

NCT02313220 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-17

No results posted yet for this study

Summary

Obesity is a medical condition which increases the risk of other diseases, such as type 2 diabetes and cardiovascular disease. Obesity-related risk factors for the development of other metabolic diseases include unstable glucose levels and high blood pressure. Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2 Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most likely via a central effect on appetite regulation. The purpose of this exploratory study is to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks with either active combination treatment or placebo (non-active treatment). Neither study personnel nor subjects will know what treatment is given. All subjects completing the 24-week double-blind study and who are willing and eligible will be offered to enter a 28-week open-label extension study. All subjects entering the extension study will receive unblinded active study treatment for an additional 28 weeks. Thus the total treatment period for subjects entering the extension study will be 52 weeks.

Conditions

Interventions

DRUG

Dapagliflozin

Oral use

DRUG

Exenatide

Powder and solvent for suspension for injection, prolonged release suspension. Subcutaneous use.

DRUG

Placebo

Oral and Subcutaneous use.

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Uppsala University

    lead OTHER

Principal Investigators

  • Jan Eriksson, Prof., MD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313220 on ClinicalTrials.gov