NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University at Buffalo
Conditions: Evaluate Ketogenic Stress
Interventions: Exenatide/Exenatide extended release, Dapagliflozin, Placebo
Countries: United States
The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Type 1 Diabetes for at least 1 year on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) * HbA1c of 7-10% (inclusive) * Ages 18-65 years (inclusive of ages 18 and 65) * BMI 20-30 kg/m2 Exclusion Criteria: * Inability to give informed consent * Inability or refusal to comply with protocol * Use of GLP-1 Receptor Agonists in the last 3 months or DPP-IV and SGLT-2 inhibitors therapy in the last 1 month. * Risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia) * History of pancreatitis and or chronic pancreatitis * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) or stroke in the previous 3 months. * Congestive Heart Failure class III or IV or tachyarrhythmia. * Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as: 1. Aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN 2. Total bilirubin \>2.0 mg/dL (34.2 µmol/L) 3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody 4. Liver function tests more than 3 times the upper limit of normal * Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR \<60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease. * History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit. * HIV positive * History of gastroparesis * History of medullary thyroid carcinoma or MEN 2 syndrome * History of recurring UTI * Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia. * Prior history of a malignant disease requiring chemotherapy or patients with a prior history of bladder cancer regardless of treatment * Alcoholism or drug addiction. * Hypertriglyceridemia (\>400 mg/dl). * Any other life-threatening, non-cardiac disease * Uncontrolled hypertension (BP \> 160/95 mm of Hg) * Patients with hypotension or at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics or recently donated \>500ml of blood should have careful monitoring of their volume status * Pregnant or breastfeeding patients or patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD) * Use of hormonal medications, anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, GnRH agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks * Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions * Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide) * Known hypersensitivity to heparin/ IV catheter equipment. * Eating disorders (anorexia, bulimia) or gastrointestinal disorders * Having a history of bariatric surgery * Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables * Use of an investigational agent or therapeutic regimen within 30 days of study * Participation in any other concurrent clinical trial
- Williamsville, New York, United States