Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open label, prospective, randomised comparative, single center study. In the present study, the impact of a 12-week pulsatile insulin infusion therapy (PIT) with Humulin R 100 from

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sciema UG
• Collaborator: Innovative Diabetes Treatment Studies LLC.
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane

Criteria

Inclusion Criteria:

1. Informed consent obtained prior to any trial-related activities

2. Male or female > 18 years

3. Diagnosed with Type 1 or 2 Diabetes ≥ 2 years

4. HbA1c <10%

5. Nephropathy with GFR between 30 and 60 mL/min/1,73m2 or < 75 GFR together with proteinuria and/or elevated creatinine levels

6. Patient is naïve to pulsatile insulin treatment

Exclusion Criteria:

1. Patients participating in another investigational drug study

2. Current or history of dialysis therapy

3. Anemia with hemoglobin < 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)