Overview
Sponsor-declared trial summary
Type 2 Diabetes Mellitus
To increase low free testosteron in men with T2D by vitamin D supplementation. Evaluation of the effect of vitamin D supplementation on the free testosteron level in men with type 2 diabetes and low testosteron level.
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 5 Dec 2018 → ongoing
- Decision date (initial)
- 2024-09-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514834-19-00
- EudraCT number
- 2018-001751-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To increase low free testosteron in men with T2D by vitamin D supplementation.
Evaluation of the effect of vitamin D supplementation on the free testosteron level in men with type 2 diabetes and low testosteron level.
Conditions and MedDRA coding
Type 2 Diabetes Mellitus
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Vitamin D < 75 nmol/L
- Caucasian men
- Age: 18 - 65 years
- BMI < 40 kg/m²
- Type 2 diabetes mellitus
- HbA1c ≤ 64 mmol/mol, ( 8%)
- Total testosteron < 11nmol/L
Exclusion criteria 13
- The use of Testosteron supplementation
- Chronic renal failure defined as eGFR less than 60 mL/min/1.73 m2 for three or more months
- Chronic liver failure defined as GOT/GPT > 2N
- Hypocalcaemia defined as calcium levels below lower limit of normal range < 2.10 mmol/L
- Hypomagnesaemia defined as magnesium < 0.65 mmol/L
- Hypoalbuminemia defined as albumin < 3 g/dL
- Hypercalcemia defined as > 2.55 mmol/L
- A history of orchidectomy
- The use of medications affecting bone turnover (cholecalciferol, vitamin K, bisphosphonates, anti-epileptic medication, corticosteroid use, heparin)
- Any supplementation containing vitamin D alone or in combination within 2 months before the screening visit and during the study
- BMI > 40 Kg/m²
- Neuroleptic treatment
- Known bone disease (osteoporosis, Paget disease, primary hyperparathyroidism)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The (change) in free testosteron concentration after 10 days and 3 months.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
D-Cure 25.000 U.I., solution buvable
PRD1656996 · Product
- Active substance
- Colecalciferol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 400000 IU/ml international unit(s)/millilitre
- Max total dose
- 4800000 IU/ml international unit(s)/millilitre
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- BE461173
- MA holder
- LABORATOIRES SMB S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Christophe Ghys
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Valérie Van Damme
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 100 | 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 |
|---|---|---|---|---|---|
| Belgium | 2018-12-05 | 2019-11-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514834-19-00 | 1 |
| Recruitment arrangements (for publication) | CTR_Transition_Statement_NA | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults_FR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults_NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC-D-Cure | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Belgium | Acceptable with conditions 2024-09-23
|
2024-09-23 |