A 24-week 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.

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 20.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-001454-33-ES
• Lead Sponsor: Dr. Albert Lecube Torello

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
F.1.3.1 Number of subjects for this age range

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
11An estimated Glomerular Filtration Rate < 60 ml/min, calculated with the Modifications of Diet Renal Disease (MDRD-4) formula.
12Inadequate liver function as shown by: Serum or plasma ALT and AST > 2.5 x ULN; Serum or plasma total bilirubin >3 x ULN
13Major medical conditions (i) vascular disease within 3 months prior to signing the consent at visit 1: myocardial infarction, cardiac surgery or revascularization, unstable angina, heart failure, any significant cerebrovascular disesase; (ii) significant hepatic disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency; (iii) history of hemoglobinopathy; and (iv) malignancy within 5 years of enrollment visit (with exception of treated basal cell or treated squamous cell carcionoma).
14Recurrent urinary tract or genital infections
15Active treatment with warfarin
16Pregnant women
17Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) who do not agree to abstain from sexual intercourse with a male partner or use a medically acceptable method of birth control (such as condom, diaphragm or cervical/vault cap with spermicide) until 28 days post-treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified