Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

1. To compare levels of ketone bodies (beta-hydroxybutyrate and acetoacetate) in plasma and urine following a single dose treatment of either liraglutide 1.8mg, dapagliflozin 10mg or placebo in insulinopenic state. 2. To compare plasma levels of free fatty acid, glucagon, hs-CRP, Ll-6 and IL-1 before and after administration of liraglutide/placebo.

Key facts

Study ID

NCT02777073

Run by

University at Buffalo

People needed

43

Starts

2016-03-01

Expected to finish

2016-12-31

Last updated by the study team

2024-02-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).
• Undetectable c peptide (c-peptide < 0.1 ng/ml).
• HbA1c of less than or equal to 8.5%.
• Age 18-75 inclusive

You may not qualify if…

• Type 1 diabetes for less than 12 months
• Coronary event/ procedure (MI, Unstable angina, CABG, PCI) in the last four weeks
• Hepatic disease (Transaminase > 3 times normal) or Cirrhosis
• Renal impairment (serum eGFR <30ml/min/1.73m2)
• HIV or Hepatitis B or C positive status
• History of pancreatitis, i.e., history of gallstones, alcohol abuse and hypertriglyceridemia
• Pregnancy
• Inability to give informed consent
• History of Gastroparesis
• Personal or Family History of medullary thyroid carcinoma or MEN 2 syndrome
• Alcoholism
• Hypertriglyceridemia (>500 mg/dl).
• Those with history of bladder cancer , diabetic ketoacidosis

Where it is running

• ECMC Ambulatory Center, 3rd Floor — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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