New onset diabetes after organ-transplantation
Conditions
Interventions
Trade Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: IU/ml international unit(s)/millilitre
Concentration typ
Sponsors
Medizinische Universität Wien, Universitätsklinik für Innere Medizin III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney. • Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dL on two occasions at least three days apart. • Patients receiving an organ transplant other than kidney. • Patients receiving an unlicensed drug or therapy within one month prior to study entry. • Patients with history of hypersensitivity to injectable insulin. • Patients with documented HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B]);Secondary Objective: • • To determine superiority of SAPT against post-transplant hyperglycemia, in comparison to basal insulin treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored basal insulin treatment group of the ITP-NODAT study [=ITP-NODAT study arm A]) • To determine if SAPT with an insulin pump for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL, can prevent intra-individually a clinically meaningful rise in HbA1c (=0.5%), measured at 3 months post-transplantation • To determine if HbA1c at 6, 12 and 24 months post-transplantation remains at the 3-months level, respectively the baseline level, intra-individually, even after intensive SAPT has been discontinued ;Primary end point(s): • HbA1c levels, in relative %, at 3 months. Superiority will be assumed if a statistically significant difference between the SAPT-treatment group versus the control group (from the ITP-NODAT study) can be determined.;Timepoint(s) of evaluation of this end point: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • HbA1c, in relative %, at 3, 6, 12 and 24 months post-transplantation; The baseline measurement will also be subtracted from the 3-, 6-, 12-, and 24-months measurement (i.e. “3-months, 6-months, 12-months, and 24-months HbA1c minus baseline HbA1c”). For the determination of the intra-individual rise in HbA1c, the previously observed rise of 0.5±0.7 % (mean ± standard deviation) from baseline to 3 months in the TIP-study basal insulin treatment group will be judged to be clinically not meaningful, hence if the intra-individual rise in the SAPT-treatment group remains below that value, the rise in HbA1c will be considered to be not meaningful, clinically. • 2h glucose =200 mg/dL, as by OGTT at 6, 12 and 24 months after transplantation (in comparison to the simultaneously monitored control group of the ITP-NODAT study [=arm B; control]) • Daily glycemia profile, through evaluation of all available glucose measurements • Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation. • Insulinogenic index during an OGTT at 6, 12 and 24 months after kidney transplantation1. • HOMA-R and QUICKI at 6, 12 and 24 months after kidney transplantation2,3. • OGIS and ISIcomp at 6, 12 and 24 months after kidney transplantation4. • Serum creatinine at 6, 12 and 24 months after kidney transplantation • Patient and graft survival at 6, 12 and 24 months after kidney transplantation • Quality of life measures (mental component summary [MCS] and physical component summary [PCS] derived from the Kidney Disease Quality of Life Short Form (KDQoL-SFTM) at 6, 12 and 24 months after kidney transplantation ;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Austria
Contacts
Public ContactStaff Physician
Med. Univ. Wien, UK für Innere III
Outcome results
None listed