Clinical trial • Phase IV|Phase II • Endocrinology
Colecalciferol for Type 2 diabetes mellitus
Phase IV|Phase II trial of Colecalciferol for Type 2 diabetes mellitus.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes mellitus
- Trial Stage
- Phase IV|Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 23-09-2024
Trial design
Randomised, placebo (matching oral solution); dose/schedule not specified-controlled Phase IV|Phase II trial across 1 site in Belgium.
- Randomised
- Yes
- Comparator
- Placebo (matching oral solution); dose/schedule not specified
- Target Sample Size
- 100
- Trial Duration For Participant
- 90
Eligibility
Recruits 100 No vulnerable populations selected; study enrols male adults only (Age 18-65). Informed consent is from adult participants. Subject information and informed consent forms for adults are available in French and Dutch (L1_ICF adults_FR, L1_ICF adults_NL). No assent process described..
- Vulnerable Population
- No vulnerable populations selected; study enrols male adults only (Age 18-65). Informed consent is from adult participants. Subject information and informed consent forms for adults are available in French and Dutch (L1_ICF adults_FR, L1_ICF adults_NL). No assent process described.
Inclusion criteria
- {"criterion_text":"- Vitamin D < 75 nmol/L\n- Caucasian men\n- Age: 18 - 65 years\n- BMI < 40 kg/m²\n- Type 2 diabetes mellitus\n- HbA1c ≤ 64 mmol/mol, ( 8%)\n- Total testosteron < 11nmol/L"}
Exclusion criteria
- {"criterion_text":"- The use of Testosteron supplementation\n- Any supplementation containing vitamin D alone or in combination within 2 months before the screening visit and during the study\n- BMI > 40 Kg/m²\n- Neuroleptic treatment\n- Known bone disease (osteoporosis, Paget disease, primary hyperparathyroidism)\n- Chronic renal failure defined as eGFR less than 60 mL/min/1.73 m2 for three or more months\n- Chronic liver failure defined as GOT/GPT > 2N\n- Hypocalcaemia defined as calcium levels below lower limit of normal range < 2.10 mmol/L\n- Hypomagnesaemia defined as magnesium < 0.65 mmol/L\n- Hypoalbuminemia defined as albumin < 3 g/dL\n- Hypercalcemia defined as > 2.55 mmol/L\n- A history of orchidectomy\n- The use of medications affecting bone turnover (cholecalciferol, vitamin K, bisphosphonates, anti-epileptic medication, corticosteroid use, heparin)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The (change) in free testosteron concentration after 10 days and 3 months.","definition_or_measurement_approach":"Change in free testosterone concentration measured at 10 days and at 3 months (timepoints specified in endpoint text)."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 133
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms available in French and Dutch (L1_ICF adults_FR, L1_ICF adults_NL). Participants provide consent themselves; no assent or vulnerable-population consent processes described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 62
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- UZ Brussel
- Department Name
- Diabetology & Endocrinology
- Contact Person Name
- Christophe Ghys
- Contact Person Email
- Christophe.Ghys@uzbrussel.be
Sponsor
Primary sponsor
- Full Name
- UZ Brussel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- D-Cure 25.000 U.I., solution buvable
- Active Substance
- Colecalciferol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (BE461173)
- Maximum Dose
- 400000 IU/ml (max daily)
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