Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
Completed · Phase 4
Conditions studied: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
In brief
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
Key facts
- Study ID
- NCT04030091
- Run by
- Sciema UG
- People needed
- 24
- Starts
- 2019-09-06
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2021-04-01
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- NYC Research, Inc. — New York, New York, United States
- Pfützner Science & Health Institute GmbH — Mainz, Rhineland-Palatinate, Germany
Full record on ClinicalTrials.gov
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