N/A
N=43
Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02777073 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin — 0.08; 0.25; 0.21 mM
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Victoza (Drug); Placebo (Drug); Dapagliflozin 10mg Tab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University at Buffalo
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin |
0.08; 0.25; 0.21 | — |
| SECONDARY Change in Glucagon Levels. |
-19; 1; -15 | — |
| SECONDARY Change in Free Fatty Acid (FFA) Concentrations |
0.1; 0.17; 0.11 | — |
| SECONDARY Change in Ghrelin Concentrations |
-32; 66; 32 | — |
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, Ll-6 and IL-1 before and after administration of liraglutide/placebo.
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).
- Undetectable c peptide (c-peptide 3 times normal) or Cirrhosis
- Renal impairment (serum eGFR 500 mg/dl).
- Those with history of bladder cancer , diabetic ketoacidosis
Data sourced from ClinicalTrials.gov (NCT02777073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.