Overview
Sponsor-declared trial summary
type 2 diabetes mellitus and gestational diabetes mellitus
The primary trial objective is to determine the concentration of metformin in plasma of breast fed infants of lactating women treated for Type 2 Diabetes.
Key facts
- Sponsor
- Uppsala Universitet
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 6 Mar 2024 → 31 Dec 2025
- Decision date (initial)
- 2024-01-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- The Innovative Medicines Initiative 2 Joint Undertaking.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The primary trial objective is to determine the concentration of metformin in plasma of breast fed infants of lactating women treated for Type 2 Diabetes.
Secondary objectives 1
- A secondary objective is to determine the milk-to-plasma ratio in the women. and, based on absolute infant dose (AID) and dosage of mother, the relative infant dose will be calculated.
Conditions and MedDRA coding
type 2 diabetes mellitus and gestational diabetes mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10018424 | Glucose metabolism disorders (incl diabetes mellitus) | 10027433 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Breastfeeding women treated with metformin for suspected or diagnosed type 2 diabetes mellitus (T2DM). Only women of 18 years of age and older will be asked for participation. Breastfeeding children of women that have consented to participate in the study. The guardians of the child are asked for participation.
Exclusion criteria 1
- Previous participation in the study. Women not able to read and communicate in Swedish, Arabic, Persian or Somali. Premature children. Women with multiple births.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the concentration of metformin in the breastfeeding child’s plasma 4h after maternal dose intake.
Secondary endpoints 1
- The secondary endpoint is the concentration of metformin in breast milk at 0h (through) and 3h after intake. The tertiary endpoint is the maternal plasma concentration of metformin at 0h (through), 2h and 3h after intake.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP135808 · ATC
- Active substance
- Metformin
- Substance synonyms
- DIMETHYLDIGUANIDE
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 3000
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uppsala Universitet
- Sponsor organisation
- Uppsala Universitet
- Address
- P. O. Box 256
- City
- Uppsala
- Postcode
- 751 05
- Country
- Sweden
Scientific contact point
- Organisation
- Uppsala Universitet
- Contact name
- Mats Hansson
Public contact point
- Organisation
- Uppsala Universitet
- Contact name
- Mats Hansson
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 30 | 2 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2024-03-06 | 2025-12-31 | 2024-03-06 | 2025-12-31 |
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) | Clinical trial protocol - Metformin V1 | 1 |
| Protocol (for publication) | EPMFrageformular1Metformin | 1 |
| Protocol (for publication) | EPMFrageformular2 Metformin pdf | 1 |
| Protocol (for publication) | EPMFrageformular3Metformin pdf | 1 |
| Protocol (for publication) | EPMFrageformular4 Metformin pdf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Metformin SmPC | 1 |
| Synopsis of the protocol (for publication) | Synopsis Metformin studie | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-19 | Sweden | Acceptable 2024-01-22
|
2024-01-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-24 | Sweden | 2024-01-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-10 | Sweden | Acceptable 2024-11-19
|
2024-11-19 |