Type 2 diabetes mellitus MedDRA version: 9.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Colecalciferol
Concentration unit: IU international unit(s)
Concentration type: equal
Concen
Sponsors
ABIOGEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -out patients with type 2 diabetes mellitus, and diabetic foot complications; -age-range: ≥ 60 years; -sex: both men and women; -patients agree to participate and give the written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -patients with previous or current tumoral disease, with less than 1 year quoad vitam prognosis; -patients with sever chronic or auto-immune inflammatory diseases; -contra-indications of Vit D (chronic renal failure, renal lithiasis, hypercalcemia, hypercalciuria, allergy to calciferole or excipients); -impossibility to perform follow up envisioned in the protocol of the study; -patients treated with strontium ranelate; -treatments effective on bone turnover , including: -bisphosphonates by I.V. or by I.M. and rhPTH by S.C. within the previous 12 months -bisphosphonates, os, for more than 14 days in the previous 12 months -calcitonin, estrogens, ipriflavon, SERMs during the last 6 months -thyroid hormone, except for in case of stable dose for the last 6 months, together with a state of euthyroidism as documented by TSH test -systemic corticosteroids for more than 3 months, at doses greater than the equivalent of 5 mg of prednisone per day, in the previous 12 months; -patients treated with antithrombotic therapies; -gastrointestinal disorders which impair drug absorption; -participation to other clinical trials in the previous 12 months; -poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of vitamin D 300.000 IU on bone metabolism;Secondary Objective: To assess the effects of vitamin D 300.000 IU on muscolar function, vascular system and infection;Primary end point(s): The main endpoint is to determine if there is an improvement in bone metabolism by means the comparison of change between baseline and after 13 and 26 weeks in beta-CTX. | — |
Countries
Italy
Outcome results
None listed