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CompletedPhase NAResults postedEffects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes
Effects of Single Doses of Liraglutide and Dapagliflozin on Hyperglycemia and Ketogenesis in Type 1 Diabetes
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
43
actual
Study population
Type 1 diabetes
Key I/E criterion
•HbA1c ≤8.5%
Primary endpoints
•Ketone bodies AUC•Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointChange in Glucagon Levels.
Time frame:8 hours
change from baseline, improvement
Cardiometabolic biomarkers
5 endpointsDifference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin
Time frame:8 hours
ketone bodies AUC
change from baseline, descriptive
Posted result
| Group | Value (mean), mM | 95% CI |
|---|---|---|
| Liraglutide 1.8 mg | 0.08 | — |
| Placebo | 0.25 | — |
| Dapagliflozin | 0.21 | — |
Change in Glucagon Levels.
Time frame:8 hours
glucagon change from baseline
change from baseline, descriptive
Posted result
| Group | Value (mean), pg/mL | 95% CI |
|---|---|---|
| Liraglutide 1.8 mg | -19 | — |
| Placebo | 1 | — |
| Dapagliflozin | -15 | — |
Change in Free Fatty Acid (FFA) Concentrations
Time frame:8 hours
Free fatty acids, change
change from baseline, improvement
Posted result
| Group | Value (mean), mM | 95% CI |
|---|---|---|
| Liraglutide 1.8 mg | 0.1 | — |
| Placebo | 0.17 | — |
| Dapagliflozin | 0.11 | — |
Change in Ghrelin Concentrations
Time frame:8 Hours
ghrelin plasma
change from baseline, descriptive
Posted result
| Group | Value (mean), pg/mL | 95% CI |
|---|---|---|
| Liraglutide 1.8 mg | -32 | — |
| Placebo | 66 | — |
| Dapagliflozin | 32 | — |
Change in Free Fatty Acid (FFA) Concentrations
Time frame:8 hours
Free fatty acids, change
change from baseline, improvement
Other (unclassified)
2 endpointsDifference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin
Time frame:8 hours
change from baseline, descriptive
Change in Ghrelin Concentrations
Time frame:8 Hours
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.