Last reviewed · How we verify

NCT02777073: 1974

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

Completed NA Results posted Last updated 29 February 2024
What this trial tests

NA trial testing Victoza in Type 1 Diabetes in 43 participants. Completed in 31 December 2016.

Timeline
1 March 2016
Primary endpoint
1 December 2016
31 December 2016

Quick facts

Lead sponsorUniversity at Buffalo
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment43
Start date1 March 2016
Primary completion1 December 2016
Estimated completion31 December 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University at Buffalo

Who can join

Adults 18 to 75, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin Primary · 8 hours

To compare levels of ketone bodies beta-hydroxybutyrate in plasma following a single dose treatment of either liraglutide 1.8mg,dapagliflozin 10mg or placebo in insulinopenic state.

GroupValue95% CI
Liraglutide 1.8 mg0.08± 0.05
Placebo0.25± 0.05
Dapagliflozin0.21± 0.05
Change in Glucagon Levels. Secondary · 8 hours

This secondary endpoint compares change in glucagon concentrations (in pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

GroupValue95% CI
Liraglutide 1.8 mg-19± 14
Placebo1± 6
Dapagliflozin-15± 5
Change in Free Fatty Acid (FFA) Concentrations Secondary · 8 hours

This secondary endpoint compares the change in FFA concentrations (mM) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

GroupValue95% CI
Liraglutide 1.8 mg0.1± 0.06
Placebo0.17± 0.06
Dapagliflozin0.11± .06
Change in Ghrelin Concentrations Secondary · 8 Hours

This secondary endpoint compares the change in ghrelin concentrations (pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo

GroupValue95% CI
Liraglutide 1.8 mg-32± 28
Placebo66± 29
Dapagliflozin32± 26

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Victoza

Trials testing the same drug.

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other University at Buffalo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02777073.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing