An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Evaluate Ketogenic Stress

In brief

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.

Key facts

Study ID

NCT02962492

Run by

University at Buffalo

People needed

70

Starts

2016-11-01

Expected to finish

2021-10-24

Last updated by the study team

2024-02-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
• Total bilirubin >2.0 mg/dL (34.2 µmol/L)
• Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
• 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

Where it is running

• Diabetes and Endocrinology Research Center of WNY — Williamsville, New York, United States

Full record on ClinicalTrials.gov

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