Status:
COMPLETED
DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a 16 week, phase 4, randomized and placebo controlled trial, investigating the separate and combined effects of Sodium Glucose coTransporter 2 (SGLT2) inhibition with dapagliflozin and Glucago...
Detailed Description
The aim of this study is to investigate 1) the seperate and 2) combined actions of SGLT2 inhibition and GLP-1 receptor agonism on food intake, body weight and the activity within the central satiety a...
Eligibility Criteria
Inclusion
- Age 18-75 years
- BMI 27-40 kg/m2
- Stable bodyweight (\<5% reported change during the previous 3 months).
- Diagnosed with T2DM \> 3 months prior to screening
- Treatment with metformin and/or sulphonylurea at a stable dose for at least 3 months.
- HbA1c 7.0-10% for patients treated with metformin
- HbA1c 7.5-10% for patients treated with metformin and/ or sulphonylurea
- For women: post menopausal (excluding possible menstruation cycle effects)
Exclusion
- GLP-1 based therapies, DDP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones or insulin within 3 months before screening
- Weight-lowering agents within 3 months before screening.
- Congestive heart failure (NYHA II-IV)
- Chronic renal failure (glomerular filtration rate \< 45 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD))
- Liver disease
- History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
- Patients with MEN2 syndrome or history or family history of medullary thyroid carcinoma
- Neurological illness
- Malignancy (except for basal cell carcinoma)
- History of major heart disease
- History of major renal disease
- Pregnancy or breast feeding
- Implantable devices
- Substance abuse
- Addiction
- Alcohol abuse (defined as: for men \> 21 units/week, for women \>14 units/week)
- Smoking/ nicotine abuse (defined as: daily smoking / a daily use of nicotine)
- Contra-indication for MRI, such as claustrophobia or pacemaker
- psychiatric illnesses; mood disorders, eating disorders, anxiety disorders, schizophrenia and other psychotic disorders, dissociative disorders, somatoform disorders, delirium, dementia and other cognitive disorders
- Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening
- Use of cytostatic or immune modulatory agents
- History of allergy for exenatide or other GLP-1 RA
- Participation in other studies
- Individuals who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Individuals who have previously completed or withdrawn from this study or any other study investigating GLP-1 receptor agonist or dipeptidyl peptidase (DPP)-4 within 6 months
- Visual disability, not correctable with glasses or contact lens
- Individuals who, in the opinion of the investigator, are unsuitable in any other way to participate in this study
- Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
- Further exclusion criteria will be in compliance with the EMeA SPC of exenatide and dapagliflozin
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03361098
Start Date
September 18 2017
End Date
March 25 2020
Last Update
June 11 2021
Active Locations (1)
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1
Amsterdam UMC, location VU Medical Center
Amsterdam, North Holland, Netherlands, 1081 HV