search
Back to results

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Glucagon
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1: Type 1 diabetes for at least 1 year. 2. Age 18 - 70 years. 3. Last known HbA1c <86 mmol/mol. 4. Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII). Exclusion Criteria: Pregnant women or women trying to conceive. Any chronic disease, including psychiatric illness, judged incompatible with participation in the study. Unfit for participation for any reason judged by the investigators. Known hypersensitivity to glucagon or any of the excipients of the drug formulation. Known phaeochromocytoma. -

Sites / Locations

  • Department of Endocrinology, St. Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Glucagon

Control

Arm Description

Micro dose of glucagon is aded at the insulin injection site

Insulin injected without any glucagon

Outcomes

Primary Outcome Measures

Area under the glucose curve
The area under the glucose curve (change from baseline glucose level)

Secondary Outcome Measures

Area under glucose curve
The area under the glucose curve (change from baseline glucose level)
Area under insulin curve
The area under the insulin curve
Area under glucagon curve
The area under the glucagon curve
Pharmacokinetics of insulin
Time to Cmax.
Pharmacokinetics of glucagon
Time to Cmax

Full Information

First Posted
June 19, 2023
Last Updated
July 17, 2023
Sponsor
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05960565
Brief Title
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Official Title
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
Detailed Description
People with type 1 diabetes will come fasting in the morning to the research facility on two separate days. Both days participants will have a breakfast of their own choice and their regular dose of meal insulin injected. Lyumjev will be used. Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours. The procedures will be exactly the same both days except that on one of the days they will be randomised to a small dose of glucagon that will be injected at exactly the same site as Lyumjev insulin is injected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
One day with glucagon and one day without glucagon
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glucagon
Arm Type
Experimental
Arm Description
Micro dose of glucagon is aded at the insulin injection site
Arm Title
Control
Arm Type
No Intervention
Arm Description
Insulin injected without any glucagon
Intervention Type
Drug
Intervention Name(s)
Glucagon
Intervention Description
A micro-dose of glucagon is added exactly at the same site as insulin is injected.
Primary Outcome Measure Information:
Title
Area under the glucose curve
Description
The area under the glucose curve (change from baseline glucose level)
Time Frame
From time 0 minutes to time 60 minutes
Secondary Outcome Measure Information:
Title
Area under glucose curve
Description
The area under the glucose curve (change from baseline glucose level)
Time Frame
Any other time span from time 0 minutes to time 180 minutes
Title
Area under insulin curve
Description
The area under the insulin curve
Time Frame
Any time frame from time 0 minutes to time 180 minutes
Title
Area under glucagon curve
Description
The area under the glucagon curve
Time Frame
Any time frame from time 0 minutes to time 180 minutes
Title
Pharmacokinetics of insulin
Description
Time to Cmax.
Time Frame
Start from time 0
Title
Pharmacokinetics of glucagon
Description
Time to Cmax
Time Frame
Start from time 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1: Type 1 diabetes for at least 1 year. 2. Age 18 - 70 years. 3. Last known HbA1c <86 mmol/mol. 4. Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII). Exclusion Criteria: Pregnant women or women trying to conceive. Any chronic disease, including psychiatric illness, judged incompatible with participation in the study. Unfit for participation for any reason judged by the investigators. Known hypersensitivity to glucagon or any of the excipients of the drug formulation. Known phaeochromocytoma. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven M Carlsen, MD, PhD
Phone
+47 91769528
Email
sven.carlsen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Hildur Henriksen, MD
Email
anne.hildur.henriksen@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven M Carlsen, MD, PhD
Organizational Affiliation
St. Olav's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven M Carlsen, MD, PhD
Phone
+47 91769528
Email
sven.carlsen@ntnu.no

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35609678
Citation
Am MK, Munkerud EY, Berge MH, Christiansen SC, Carlsen SM. The effect of glucagon on local subcutaneous blood flow in non-diabetic volunteers; a proof-of-concept study. Eur J Pharmacol. 2022 Jul 5;926:175045. doi: 10.1016/j.ejphar.2022.175045. Epub 2022 May 21.
Results Reference
background
PubMed Identifier
36213069
Citation
Teigen IA, Riaz M, Am MK, Christiansen SC, Carlsen SM. Vasodilatory effects of glucagon: A possible new approach to enhanced subcutaneous insulin absorption in artificial pancreas devices. Front Bioeng Biotechnol. 2022 Sep 21;10:986858. doi: 10.3389/fbioe.2022.986858. eCollection 2022.
Results Reference
background

Learn more about this trial

Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1

We'll reach out to this number within 24 hrs