Pulsatile insulin infusion therapy (PIT) for diabetics

Phase 1

• Conditions: treatment of long-term effects of Diabetes Type 1 and Type 2; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2019-002758-21-DE
• Lead Sponsor: Innovative Diabetes Treatments Studies LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-11
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Male or female > 18 years =70
•Diagnosed with Type 1 or 2 Diabetes = 2 years
•HbA1c <10%
•Nephropathy with GFR between 30 and 60 mL/min/1,73m2 or < 75 GFR together with proteinuria and/or elevated creatinine levels
•Patient is naïve to pulsatile insulin treatment
•Stable insulin treatment for at least the last 3 months

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 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

1.Patients participating in another investigational drug study
2.Current or history of dialysis therapy
3.Anemia with HgB < 10 g/dL
4.Unstable significant cardiovascular disease with admission to emergency room or hospital in last 45 days
5.Patients with diagnosed renal failure from non-diabetic etiology
6.Pregnancy or breast feeding
7.Patient unwillingness to use a CGM device, or inability (with or without family assistance) to replace the sensor every two weeks on the study CGM device
8.Drug or alcohol abuse
9.Sexually active woman of childbearing age not practicing birth control by accepted methods
10.Lack of compliance or other reason that in the discretion of the investigator precludes satisfactory participation in the study
11.Any severe illness preventing participation in the study per protocol (in the discretion of the investigator)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Impact of PIT on endothelial function and renal failure;Secondary Objective: • impact of PIT on renal function parameters<br>• impact of PIT on retinopathy <br>• impact of PIT on neuropathy<br>• impact of PIT on gylcemic control (HbA1c)<br>• impact of PIT on Quality of Life<br>•Demonstrate safety of PIT<br>;Primary end point(s): endothelial function<br>renal failure;Timepoint(s) of evaluation of this end point: endothelial function (Visit 2, 6, 10, and 14)<br>renal failure (Visit 2 and 14)