Improving Secretion of Insulin in New Onset Diabetes after Renal Transplantation (ISINODAT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012712-40-AT

Enrollment

Registered

2009-07-16

Start date

2009-07-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New onset diabetes mellitus after renal transplantation

Interventions

Trade Name: Sandimmun Neoral ® Product Name: Sandimmun Neoral ® Pharmaceutical Form: Capsule, hard INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose): glucose = 200mg/dl • Defect in insulin secretion as judged by OGTT and HOMA B • renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction • stable graft function for more than 3 months post transplant • 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 prior history of type 1 or type 2 diabetes • allergy against long-acting insulin or cyclosporine A • isolated defect in insulin sensitivity without decreased insulin secretion • body mass index (BMI) > 35 • pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: • To assess whether Sandimmun® -based immunosuppression is superior to Prograf® -based immunosuppression in patients with newly diagnosed NODAT as judged by change in OGTT 90 days after conversion.;Secondary Objective: • To assess whether Sandimmun®-based immunosuppression is superior to Prograf®-based immunosuppression in patients with newly diagnosed NODAT as judged by change in OGTT 180 days after conversion. • To assess differences in the change in HbA1c after 90 and 180 days • To assess the difference in insulin secretory capacity and insulin sensitivity in both groups after 90 and 180 days after conversion • To assess the renal outcome (creatinine levels, rejections) in both groups of patients • To assess the duration of treatment with long-acting insulin (Insulatard®) that is necessary to reach normoglycaemia in both groups • To assess the morbidity (hospitalization, infections, subsequent episodes of surgery, requirement of non-immunosuppresive, non- blood glucose lowering medication) in both groups of patients ;Primary end point(s): • Primary endpoint will be the difference in the performance at an OGTT (2h, 75g Glucose) on day 90 after study start compared to baseline.	—

Measure

Time frame

Main Objective: • To assess whether Sandimmun® -based immunosuppression is superior to Prograf® -based immunosuppression in patients with newly diagnosed NODAT as judged by change in OGTT 90 days after conversion.;Secondary Objective: • To assess whether Sandimmun®-based immunosuppression is superior to Prograf®-based immunosuppression in patients with newly diagnosed NODAT as judged by change in OGTT 180 days after conversion. • To assess differences in the change in HbA1c after 90 and 180 days • To assess the difference in insulin secretory capacity and insulin sensitivity in both groups after 90 and 180 days after conversion • To assess the renal outcome (creatinine levels, rejections) in both groups of patients • To assess the duration of treatment with long-acting insulin (Insulatard®) that is necessary to reach normoglycaemia in both groups • To assess the morbidity (hospitalization, infections, subsequent episodes of surgery, requirement of non-immunosuppresive, non- blood glucose lowering medication) in both groups of patients ;Primary end point(s): • Primary endpoint will be the difference in the performance at an OGTT (2h, 75g Glucose) on day 90 after study start compared to baseline.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026