Type 2 Diabetes mellitus MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Dr. Albert Lecube Torello
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male or female subjects aged between 18 and 60 years. 2 BMI of = 35.0 - = 42.5 Kg/m2. 3 Type-2 diabetes mellitus 4 HbA1c = 7.0 - = 10.0%. 5 Willing 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
Exclusion criteria: 1 Known type-1 diabetes or LADA diabetes 2 Medication-induced obesity: Glucocorticoid and antipsychothic therapies 3 Patients with a change of =5% of their reported body weight reported change within the previous 3 months. 4 Previous surgical obesity treatment 5 Use of approved weight lowering pharmacotherapy 6 Active treatment with GLP-1RA 7 Active treatment with SGLT2i 8 Current drug or alcohol abuse 9 Uncontrolled psychiatric illness 10 History of acute or chronic pancreatitis, cholelithiasis, personal or familial history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or recurrent genital infections 11 An estimated Glomerular Filtration Rate 2.5 x ULN; Serum or plasma total bilirubin >3 x ULN 13 Major 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). 14 Recurrent urinary tract or genital infections 15 Active treatment with warfarin 16 Pregnant women 17 Women 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 24-week GLP-1ra plus SGLT2i based therapy (exenatide 2.0 mg once weekly plus dapaglifozine 10 mg once daily) compared to traditional management of the disease in the proportion of patients with T2D awaiting for bariatric surgery who will run off the National Institutes of Health criteria.;Primary end point(s): The primary endpoint for the study is the proportion of patients who do not accomplish with the National Health criteria for bariatric surgery. This is the proportion of patients who achieve, after 24-weeks of therapy, a BMI = 35.0 kg/m2 or a BMI = 40.0 kg/m2 plus an HbA1c = 6.0%.;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment;Secondary Objective: 1. To assess Changes in body weight and classification of weight category by BMI. 2. To assess the percentage of patients who achieve both a 5% and 10% decrease in body weight. 3. Changes in neck circumference 4. To assess the percentage of patients, who achieve a decrease of 1% in their HbA1c level. 5. To assess the changes in glucose metabolism, therapy, and diabetes 6. To assess the changes in blood pressure, therapy, and hypertensive status. 7. To assess the changes in fasting lipids, therapy. 8. To assess the changes on the obstructive apnoea syndrome severity. 9. To assess the changes in quality of life and proportion of patients that refuse the surgery option. 10. To assess the proportion of patients who achieve the composite objective of a significantly decrease in both body weight (5% decrease in body weight or higher) and/or HbA1c levels (1% decrease in HbA1c or higher) from baseline to 24-weeks of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anthropometric data: body weight, classification of weight category by BMI (< 35 kg/m2, = 35 - < 40 kg/m2, and = 40 kg/m2), waist circumference and neck circumference. We will also evaluate decreases of both 5% and 10% of baseline body weight and waist circumference at the end of the treatment period. 2. Parameters from glucose metabolism (fasting plasma glucose, fasting insulin, and HbA1c), hypoglycaemic therapy requirements, and diabetes status. Percentage of patients who decrease their baseline HbA1c more than 1%, and percentage of patients with HbA1c = 7.0% and HbA1c = 6.0% at the end of the treatment period. We will also classify patients on complete and partial remission. 3. Systolic and diastolic blood pressure, antihypertensive therapy requirements, and we will classify patients according to their hypertensive status (complete or partial remission). 4. Parameters from lipid metabolism (fasting total cholesterol, low-density lipoprotein cholesterol, very-low density lipoprotein cholesterol, and triglycerides), and hypolipemic therapy requirements. 5. Parameters from a non-attended respiratory polygraphy [apnoea-hypopnea index (AHI) and cumulative percentage of sleeping time spent with oxygen saturations below 90% (CT90)] and the obstructive apnoea syndrome severity. The daytime sleepiness will also be assessed through the Epworth Sleepiness Test (ESS). 6. Quality of life assessed by the Impact of Weight Quality of Life (IWQOL) questionnaire. 7. The proportion of patients awaiting bariatric surgery that still fulfilling the National Institutes of Health criteria refuses this treatment option. 8. The proportion of patients who achieve the composite objective of a significantly decrease in both body weight (5% decrease in body weight or higher) and/or HbA1c (1% decrease in HbA1c or higher) levels from baseline to 24-weeks of therapy.;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment | — |
Countries
Spain
Contacts
Public ContactRaúl Montalbán Casado
Dynamic Science SL..
Outcome results
None listed