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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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, Il-6 and IL-1 before and after administration of liraglutide/Dapagliflozin/placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Treatments: Dapagliflozin; Liraglutide

Criteria

Inclusion Criteria:

1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).

2. Undetectable c peptide (c-peptide < 0.1 ng/ml).

3. HbA1c of less than or equal to 8.5%.

4. Age 18-75 inclusive

Exclusion Criteria:

1. Type 1 diabetes for less than 12 months

2. Coronary event/ procedure (MI, Unstable angina, CABG, PCI) in the last four weeks

3. Hepatic disease (Transaminase > 3 times normal) or Cirrhosis

4. Renal impairment (serum eGFR <30ml/min/1.73m2)

5. HIV or Hepatitis B or C positive status

6. History of pancreatitis, i.e., history of gallstones, alcohol abuse and hypertriglyceridemia

7. Pregnancy

8. Inability to give informed consent

9. History of Gastroparesis

10. Personal or Family History of medullary thyroid carcinoma or MEN 2 syndrome

11. Alcoholism

12. Hypertriglyceridemia (>500 mg/dl).

13. Those with history of bladder cancer , diabetic ketoacidosis