Type-2 diabetes MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: TESAVEL - 100 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER (PVC/PE/PVDC/ALU) - 30 COMPRESSE
Product Name: Tesavel
Product Code: [NA]
Pharmaceutical Form: Film-coated tablet
INN
Sponsors
UMBERTO I - POLICLINICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female subjects = 18 years - Diagnosis of Type 2 Diabetes according to American Diabetes Association 2009 criteria - Body mass index (BMI) between 20-40 kg/m2 - Body weight = 120 kg (due to limitations imposed by DXA equipment); - HbA1c 40 mIU/mL; or 2) a woman 55 or holder not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or 3) a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy - Women of childbearing potential participating: I) cannot be pregnant or intend to become pregnant II) cannot be breastfeeding III) must remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study IV) test negative for pregnancy at the time of screening 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 132 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Treatments known to significantly influence bone metabolism (e.g. bisphosphonates, calcitonin, corticosteroids or hormone replacement therapy) - Osteomalacia - Pagets disease - Hyperparathyroidism - Hyperthyroidism - Chronic liver failure/cirrhosis - Kidney failure - Current or history of therapy with antidiabetic agents other than metformin - Pregnancy/lactation, childbearing potential women who do not give their consent to remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study - Substance abuse, clinically significant depression or current psychiatric care - Refuse or are unable to give informed consent to participate in the study Subjects taking vitamin D and/or calcium supplements at enrolment will be instructed to continue this therapy keeping the doses unchanged throughout the entire study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a superiority, double-blinded, randomized, placebo-controlled clinical trial aiming to investigate the safety and efficacy of 52-week sitagliptin 100 mg therapy in improving bone outcomes in women affected by type 2 diabetes. In particular, primary objective of this study will be: - to test the superiority of sitagliptin 100 mg in add-on to metformin versus placebo + metformin in improving bone mineral density from baseline to end of treatment (week 52), estimated by DXA on lumbar spine and femoral neck. ;Secondary Objective: Secondary endpoints are: - to evaluate the association between circulating DPP4 activity and serum markers of bone metabolism at baseline and after 24- and 52-week sitagliptin supplementation. - to ascertain whether circulating DPP4 activity is associated with impaired vitamin D availability and, thus, whether chronic DPP4 inhibition induce changes in serum vitamin D levels after treatment. - to study the relationship between DPP4 activity and systemic markers of inflammation, closely related to impaired glucose metabolism, at baseline and after 24- and 52-week sitagliptin supplementation ;Primary end point(s): To test the superiority of sitagliptin 100 mg in add-on to metformin versus placebo + metformin in improving bone mineral density from baseline to end of treatment (week 52), estimated by DXA on lumbar spine and femoral neck;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - to evaluate the association between circulating DPP4 activity and serum markers of bone metabolism at baseline and after 24- and 52-week sitagliptin supplementation; - to ascertain whether circulating DPP4 activity is associated with impaired vitamin D availability and, thus, whether chronic DPP4 inhibition induce changes in serum vitamin D levels after treatment; - to study the relationship between DPP4 activity and systemic markers of inflammation, closely related to impaired glucose metabolism, at baseline and after 24- and 52-week sitagliptin supplementation;Timepoint(s) of evaluation of this end point: 24 and 52 weeks; 24 and 52 weeks; 24 and 52 weeks | — |
Countries
Italy
Contacts
Public ContactDipartimento di Medicina Sperimenta
Azienda Policlinico Umberto I
Outcome results
None listed