Overview
Sponsor-declared trial summary
Type 1 diabetes
a) To investigate if adding 100 ng glucagon/unit insulin increases the speed of absorption of SC injected insulin in patients with T1D b) To investigate if adding 100 ng glucagon/unit insulin increases the effect on glucose metabolism insulin in patients with T1D
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
- 1 Apr 2025 → ongoing
- Decision date (initial)
- 2025-01-23
- Transition trial
- No
- Low-intervention
- No
- 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: Pharmacodynamic, Therapy
a) To investigate if adding 100 ng glucagon/unit insulin increases the speed of absorption of SC injected insulin in patients with T1D
b) To investigate if adding 100 ng glucagon/unit insulin increases the effect on glucose metabolism insulin in patients with T1D
Conditions and MedDRA coding
Type 1 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10012608 | Diabetes mellitus insulin-dependent | 10027433 |
| 21.1 | LLT | 10045228 | Type I diabetes mellitus | 10027433 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- This is a small single center prooof of concept study and no IPD will be shared with other researchers or organizations
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-510408-32-00 | Premixed glucagon/insulin solution for faster insulin absorption in Type 1 diabetes. | St. Olavs Hospital HF |
| 2022-502455-57-01 | Glucagon enhanced insulin absorption in Diabetes Mellitus type 1 | St. Olavs Hospital HF |
| 2023-510408-32-01 | Premixed glucagon/insulin solution for faster insulin absorption in Type 1 diabetes. | St. Olavs Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. T1D for at least one year.
- 2. Age 18 – 70 years.
- 3. Last known HbA1c <75 mmol/mol (< 9.0%).
- 4. Treated with an insulin pump or a hybrid artificial pancreas (AP).
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 to any of the excipients of the drug formulations.
- 5. Known phaeochromocytoma.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The area under the glucose consumption curve and area under the insulin curve for the first 30 minutes.
Secondary endpoints 4
- Area under glucose consumption curve for any other time span during the first 4 hours
- Area under insulin curve for any other time span during the first 4 hours
- Pharmacokinetic estimates for insulin
- Pharmacodynamic estimates for insulin
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB02347MIG · Substance
- Active substance
- Glucagon
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.5 µg microgram(s)
- Max total dose
- 0.5 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Mixed with insulin giving a solution with 50 ng glucagon/unit insulin
Lyumjev 100 units/mL solution for injection in vial
PRD7958890 · Product
- Active substance
- Insulin Lispro
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 20 IU international unit(s)
- Max total dose
- 40 IU international unit(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10AB04 — INSULIN LISPRO
- Marketing authorisation
- EU/1/20/1422/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lyumjev is mixed with glucagon to a solution containing 50 ng glucagon/unit insulin
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
- Sven M Carlsen
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Sven M Carlsen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Temporarily halted | 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 | 2025-04-01 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-83580
- Halt date
- 2025-05-21
- Member states concerned
- Norway
- Publication date
- 2025-05-22
- Reason
- Investigator/Site related
- Explanation
- The effect seems to be too small to be clinically relevant
- Follow-up measures
- none for subjects
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol redacted | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults NO redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Glucagon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPc Insulin Lyumjev | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_ENG_Redacted | 4 |
| Synopsis of the protocol (for publication) | Protocol synopsis_NO_redacted | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-06 | Norway | Acceptable 2025-01-23
|
2025-01-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-28 | Norway | Acceptable 2026-01-08
|
2026-01-16 |