Primary outcome
What 1974 measured first
| Liraglutide 1.8 mgn=13 | Placebon=13 | Dapagliflozinn=17 |
|---|---|---|
| 0.08(0.05) | 0.25(0.05) | 0.21(0.05) |
NA · Liraglutide
1974 trial results
Effects of Single Doses of Liraglutide and Dapagliflozin on Hyperglycemia and Ketogenesis in Type 1 Diabetes
Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin (mM), 8 hours. Liraglutide 1.8 mg: 0.08; Placebo: 0.25; Dapagliflozin: 0.21.
- Participants
- 43
- Status
- completed
- Completed
- 2016-12-31
- Sponsor
- University at Buffalo
As posted on ClinicalTrials.gov (NCT02777073), updated at source Feb 29, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Secondary outcomes
What else it measured
| Liraglutide 1.8 mgn=13 | Placebon=13 | Dapagliflozinn=17 |
|---|---|---|
| -19(14) | 1(6) | -15(5) |
| Liraglutide 1.8 mgn=13 | Placebon=13 | Dapagliflozinn=17 |
|---|---|---|
| 0.1(0.06) | 0.17(0.06) | 0.11(.06) |
| Liraglutide 1.8 mgn=13 | Placebon=13 | Dapagliflozinn=17 |
|---|---|---|
| -32(28) | 66(29) | 32(26) |
The trial
How 1974 was run
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.
- liraglutide 1.8 mg: single dose of Victoza ( liraglutide) 1.8 mg
- Placebo: Single dose of placebo
- Dapagliflozin: Single dose of Dapagliflozin 10 mg oral tablet
Who could join the trial
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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