EUCTR2017-001454-33-ES
Active, not recruiting
Phase 1
A randomized, non-blinded, 24-week pilot study to evaluate the effect of dapagliflozin (10 mg once daily) plus exenatide (2.0 mg once weekly) on type 2 diabetic patients awaiting for bariatric surgery. DEXBASU study - DEXBAS
Dr. Albert Lecube Torello0 sitesJune 22, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes mellitus
- Sponsor
- Dr. Albert Lecube Torello
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1Male or female subjects aged between 18 and 60 years.
- •2BMI of \= 35\.0 \- \= 42\.5 Kg/m2\.
- •3Type\-2 diabetes mellitus
- •4HbA1c \= 7\.0 \- \= 10\.0%.
- •5Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 56
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1Known type\-1 diabetes or LADA diabetes
- •2Medication\-induced obesity: Glucocorticoid and antipsychothic therapies
- •3Patients with a change of \=5% of their reported body weight reported change within the previous 3 months.
- •4Previous surgical obesity treatment
- •5Use of approved weight lowering pharmacotherapy
- •6Active treatment with GLP\-1RA
- •7Active treatment with SGLT2i
- •8Current drug or alcohol abuse
- •9Uncontrolled psychiatric illness
- •10History of acute or chronic pancreatitis, cholelithiasis, personal or familial history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or recurrent genital infections
Outcomes
Primary Outcomes
Not specified
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