new onset diabetes mellitus after transplantation
Conditions
Interventions
Trade Name: Actos
Product Name: Actos
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazon
CAS Number: 112529-15-4
Other descriptive name: PIOGLITAZONE HYDROCHLORIDE
Concentration unit: mg mil
Sponsors
Medizinische Universität Wien, Univ.Klinik Innere Medizin III, Abt.für Nephrologie u.Dialyse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Time since renal transplantation > 6 months • Stable graft function • Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl) • Informed consent of the patient 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 type 1 or type 2 diabetes • Patients with NODAT (2h glucose level at OGTT >200 mg/dl) • allergy against vildagliptin or pioglitazone • pregnancy • GFR < 30 ml/min • hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate that glucose control under vildagliptin and pioglitazone in stable renal transplant patients after post-transplant month 6 with newly diagnosed pre-diabetes is superior to placebo, as judged by change in OGTT 90 days after drug-administration;Secondary Objective: •To demonstrate that glucose control under vildagliptin and pioglitazone in stable renal transplant patients after post-transplant month 6 with newly diagnosed pre-diabetes is superior to placebo, as judged by change in HbA1c 90 days after drug-administration •differences in insulin secretory capacity and insulin sensitivity 90 days after administration of vildagliptin and pioglitazone versus placebo •differences in renal function 90 days after drug-administration and upon routine outpatient visits •differences in blood lipids 90 days after study start, in comparison to baseline and among the different study groups •safety of vildagliptin and pioglitazone in pre-diabetic renal transplant patients •side-effects of vildagliptin and pioglitazone in pre-diabetic renal transplant patients •morbidity in all three groups of patients •efficacy of oral antidiabetic agents for pre-diabetics depends on the time-point of treatment initiation ;Primary end point(s): • Glucose control, as estimated by differences in performance at an OGTT (2h, 75 g glucose) on day 90 after study start, compared among the different study groups | — |
Countries
Austria
Outcome results
None listed