Primary outcomeMean· 8 hours
Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin
| Group | Value (mM) | Spread |
|---|---|---|
| Liraglutide 1.8 mg | 0.08 | 0.05 |
| Placebo | 0.25 | 0.05 |
| Dapagliflozin | 0.21 | 0.05 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes
Short name 1974
NCTNCT02777073 (opens ClinicalTrials.gov in a new tab)Other id1974
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 43 participants (actual)
- Sponsor
- University at Buffalo · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- 1 Mar 2016
- Primary completion
- 1 Dec 2016
- Completion
- 31 Dec 2016
- First posted
- 19 May 2016 (estimated)
- Last update posted
- 29 Feb 2024
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20162017
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- VictozaDrug
- PlaceboDrug
- Dapagliflozin 10mg TabDrug
Arms3
Active comparator
liraglutide 1.8 mg
single dose of Victoza ( liraglutide) 1.8 mg
Placebo comparator
Placebo
Single dose of placebo
Active comparator
Dapagliflozin
Single dose of Dapagliflozin 10 mg oral tablet
Primary outcomes1
Outcomes the sponsor listed as primary.
Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin
Time frame · 8 hours
Registry description
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.
Secondary outcomes(3)
Change in Glucagon Levels.
Time frame · 8 hours
Registry description
This secondary endpoint compares change in glucagon concentrations (in pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo
Change in Free Fatty Acid (FFA) Concentrations
Time frame · 8 hours
Registry description
This secondary endpoint compares the change in FFA concentrations (mM) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo
Change in Ghrelin Concentrations
Time frame · 8 Hours
Registry description
This secondary endpoint compares the change in ghrelin concentrations (pg/ml) from baseline at 8 hours following liraglutide and dapagliflozin compared to placebo
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· 8 hours
Change in Glucagon Levels.
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Liraglutide 1.8 mg | -19 | 14 |
| Placebo | 1 | 6 |
| Dapagliflozin | -15 | 5 |
Secondary outcomeMean· 8 hours
Change in Free Fatty Acid (FFA) Concentrations
| Group | Value (mM) | Spread |
|---|---|---|
| Liraglutide 1.8 mg | 0.1 | 0.06 |
| Placebo | 0.17 | 0.06 |
| Dapagliflozin | 0.11 | .06 |
Secondary outcomeMean· 8 Hours
Change in Ghrelin Concentrations
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Liraglutide 1.8 mg | -32 | 28 |
| Placebo | 66 | 29 |
| Dapagliflozin | 32 | 26 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide 1.8 mgsingle dose of Victoza ( liraglutide) 1.8 mg Victoza: Single dose of Liraglutide | 0 / 13 | 0 / 13 | 0 / 13 |
| DapagliflozinSingle dose of dapagliflozin 10 mg | 0 / 17 | 0 / 17 | 0 / 17 |
| PlaceboSingle dose of placebo Placebo: Single dose of generic placebo | 0 / 13 | 0 / 13 | 0 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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