Overview
Sponsor-declared trial summary
Diabetes mellitus type 1
To investigate if micro-doses of glucagon at the same site as subcutaneous insulin delivery enhances the absorption of insulin and reduces postprandial glucose excursions in patients with diabetes mellitus type 1
Key facts
- Sponsor
- St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 20 Jun 2023 → 22 Dec 2023
- Decision date (initial)
- 2023-03-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- NTNU Technology Transfer Office
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacodynamic
To investigate if micro-doses of glucagon at the same site as subcutaneous insulin delivery enhances the absorption of insulin and reduces postprandial glucose excursions in patients with diabetes mellitus type 1
Secondary objectives 1
- To test two doses of glucagon, 0.1 mg and 0.01 mg
Conditions and MedDRA coding
Diabetes mellitus type 1
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502455-57-00 | Glucagon enhanced insulin absorption in Diabetes Mellitus type 1 | St. Olavs Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. DM1 for at least 1 year.
- 2. Age 18 – 70 years
- 3. Last known HbA1c <86 mmol/mol (< 10.0%)
- 4. Treated with continuous SC insulin infusion (CSII) by an insulin pump or with multiple daily insulin injections (MDII).
Exclusion criteria 5
- 1. Pregnant women or women trying to conceive (women will not be screened by a pregnancy test).
- 2. Any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study.
- 3. Unfit for participation for any reason as judged by the investigators
- 4. Known hypersensitivity to glucagon or any of the excipients of the drug formulation
- 5. Known phaeochromocytoma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Area under the glucose curve for the first 60 minutes.
Secondary endpoints 7
- Area under glucose curve for any other time span during the first 3 hours.
- Area under the insulin curve for any time span during the first 3 hours
- Area under the glucagon curve for any time span during thefirst 3 hours.
- Pharmacokinetic estimates for insulin.
- Pharmacokinetic estimates for glucagon.
- Thermal camera measurements.
- Laser doppler flowmetry measurements.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP54118154 · ATC
- Active substance
- Glucagon
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 30 IU international unit(s)
- Max total dose
- 30 IU international unit(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H04AA01 — GLUCAGON
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- Prinsesse Kristinas G. 3
- City
- Trondheim
- Postcode
- 7030
- Country
- Norway
Scientific contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Forskningsavdelingen
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Forskningsavdelingen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2023-06-20 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-15550
- Halt date
- 2023-09-29
- Member states concerned
- Norway
- Publication date
- 2024-02-29
- Reason
- Sponsor decision
- Explanation
- No sign of the effect that was anticipated. In previous pig trials we used acostum made introducer to secure that glucagon was deposited at the axect same site as insulin. However, we were not able to used this in the present study as it was considered as a medical device that we had not applied for to use. So we belive that the cause of no effect is tha glucagon ws deposited at free hand and did not reach the correct subcutaneous site.
- Follow-up measures
- None as the follow up was only for 24 hours after the second intervention day and all participants were far beyound that.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Effect of micro amounts of glucagon on subcutaneous insulin absorption SUM-60630
|
2024-11-29T13:40:46 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary. Glucagon enhanced insulin absorption in Diabetes Mellitus type 1 | 2024-11-25T14:37:01 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Summary | 1 |
| Summary of results (for publication) | Effect of micro amounts of glucagon on subcutaneous insulin absorption | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-20 | Norway | Acceptable 2023-03-29
|
2023-03-29 |