NCT02777073

Brief Summary

  1. 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. 2.To compare plasma levels of free fatty acid, glucagon, hs-CRP, Ll-6 and IL-1 before and after administration of liraglutide/placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

December 1, 2015

Results QC Date

October 31, 2022

Last Update Submit

February 3, 2024

Conditions

Type 1 Diabetes

Keywords

Diabetic ketoacidosisInsulinType 1 Diabetesglucose (sugar) control

Outcome Measures

Primary Outcomes (1)

  • Difference in Ketone Bodies Formation After Single Dose of Liraglutide and Dapagliflozin

    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.

    8 hours

Secondary Outcomes (3)

  • Change in Glucagon Levels.

    8 hours

  • Change in Free Fatty Acid (FFA) Concentrations

    8 hours

  • Change in Ghrelin Concentrations

    8 Hours

Study Arms (3)

liraglutide 1.8 mg

ACTIVE COMPARATOR

single dose of Victoza ( liraglutide) 1.8 mg

Drug: Victoza

Placebo

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Dapagliflozin

ACTIVE COMPARATOR

Single dose of Dapagliflozin 10 mg oral tablet

Drug: Dapagliflozin 10mg Tab

Interventions

VictozaDRUG

Single dose of Liraglutide

Also known as: Liraglutide
liraglutide 1.8 mg
PlaceboDRUG

Single dose of generic placebo

Placebo
Dapagliflozin 10mg TabDRUG

single dose of 10 mg dapagliflozin

Also known as: Dapagliflozin
Dapagliflozin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).
  • Undetectable c peptide (c-peptide \< 0.1 ng/ml).
  • HbA1c of less than or equal to 8.5%.
  • Age 18-75 inclusive

You may not qualify if:

  • Type 1 diabetes for less than 12 months
  • Coronary event/ procedure (MI, Unstable angina, CABG, PCI) in the last four weeks
  • Hepatic disease (Transaminase \> 3 times normal) or Cirrhosis
  • Renal impairment (serum eGFR \<30ml/min/1.73m2)
  • HIV or Hepatitis B or C positive status
  • History of pancreatitis, i.e., history of gallstones, alcohol abuse and hypertriglyceridemia
  • Pregnancy
  • Inability to give informed consent
  • History of Gastroparesis
  • Personal or Family History of medullary thyroid carcinoma or MEN 2 syndrome
  • Alcoholism
  • Hypertriglyceridemia (\>500 mg/dl).
  • Those with history of bladder cancer , diabetic ketoacidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic KetoacidosisInsulin Resistance

Interventions

Liraglutidedapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesKetosisAcidosisAcid-Base ImbalanceDiabetes ComplicationsHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Paresh Dandona
Organization
State University of NY at Buffalo
dandona@buffalo.edu
7165351850

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

December 1, 2015

First Posted

May 19, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 31, 2016

Last Updated

February 29, 2024

Results First Posted

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)