NCT05804513

Brief Summary

The current study has two aims:

  1. 1.to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;
  2. 2.to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

March 27, 2023

Last Update Submit

June 9, 2023

Conditions

HealthyType 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Growth hormone area under the curve.

    Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers.

    0-150 minutes after study drug administration

Secondary Outcomes (8)

  • Growth hormone peak

    30, 60, 90, 120, and 150 minutes after the study drug administration.

  • Glucose nadir

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • C-peptide peak

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • Cortisol peak

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • Adrenocorticotropic hormone (ACTH) peak

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • +3 more secondary outcomes

Other Outcomes (3)

  • Nausea

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • Systolic and diastolic blood pressure

    30, 60, 90, 120, and 150 minutes after the study drug administration

  • Heart rate

    30, 60, 90, 120, and 150 minutes after the study drug administration.

Study Arms (4)

Placebo, healthy volunteers

PLACEBO COMPARATOR

Sodium chloride 0.9% solution. Subcutaneous injection administered once.

Drug: Placebo

Lixisenatide 10 micrograms, healthy volunteers

ACTIVE COMPARATOR

Lixisenatide 10 micrograms. Subcutaneous injection administered once.

Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector

Placebo, type 1 diabetic patients

PLACEBO COMPARATOR

Sodium chloride 0.9% solution. Subcutaneous injection administered once.

Drug: Placebo

Lixisenatide 10 micrograms, type 1 diabetic patients

ACTIVE COMPARATOR

Lixisenatide 10 micrograms. Subcutaneous injection administered once.

Drug: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector

Interventions

PlaceboDRUG

s/c injection

Also known as: Sodium chloride 0.9% solution
Placebo, healthy volunteersPlacebo, type 1 diabetic patients
Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen InjectorDRUG

s/c injection

Also known as: Lyxumia
Lixisenatide 10 micrograms, healthy volunteersLixisenatide 10 micrograms, type 1 diabetic patients

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers:
  • male sex
  • age 18-60 years
  • body weight \> 65 kg
  • Patients with type 1 diabetes:
  • type 1 diabetes
  • male sex
  • age 18-60 years
  • body weight \> 65 kg
  • c-peptide in fasting blood sample \<0,1 nmol/l
  • HbA1c \< 8,5%

You may not qualify if:

  • Healthy volunteers:
  • use of aldosterone antagonist
  • use of glucocorticosteroid
  • use of other medication that potentially significantly affects pituitary function.
  • Patients with type 1 diabetes:
  • use of aldosterone antagonist
  • use of glucocorticosteroid
  • use of other medication that potentially significantly affects pituitary function.
  • The patient is excluded from the study if a significant change in blood glucose occurs in the study center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sodium ChlorideSolutionslixisenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical Preparations

Study Officials

  • Vallo Volke, MD, PhD

    University of Tartu, Tartu University Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vallo Volke, MD, PhD

CONTACT

7374330vallo.volke@ut.ee

Ingrid Reppo, MD

CONTACT

53318642ingrid.reppo@kliinikum.ee

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Blinded randomised two group crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

April 17, 2023

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

ES(1)