Status:
COMPLETED
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
Lead Sponsor:
Sciema UG
Collaborating Sponsors:
Innovative Diabetes Treatment Studies LLC.
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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
Detailed Description
During the screening visit the patient will arrive at the study site and written informed consent will be obtained. Inclusion and exclusion criteria will be controlled and blood will be drawn for HbA1...
Eligibility Criteria
Inclusion
- Informed consent obtained prior to any trial-related activities
- Male or female \> 18 years
- 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
Exclusion
- Patients participating in another investigational drug study
- Current or history of dialysis therapy
- Anemia with hemoglobin \< 10 g/dL
- Unstable significant cardiovascular disease with admission to emergency room or hospital in last 45 days
- Patients with diagnosed renal failure from non-diabetic etiology
- Pregnancy or breast feeding
- 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
- Drug or alcohol abuse
- Sexually active woman of childbearing age not practicing birth control by accepted methods
- Lack of compliance or other reason that in the discretion of the investigator precludes satisfactory participation in the study
- Any severe illness preventing participation in the study per protocol (in the discretion of the investigator)
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04030091
Start Date
September 6 2019
End Date
December 31 2020
Last Update
April 1 2021
Active Locations (2)
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1
NYC Research, Inc.
New York, New York, United States, 10455
2
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany, 55128