treatment of long-term effects of Diabetes Type 1 and Type 2
Conditions
Interventions
Trade Name: Huminsulin Normal 100
Product Name: Huminsulin Normal 100
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Other descriptive name: Humi
Sponsors
Innovative Diabetes Treatments Studies LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female > 18 years =70 • Diagnosed with Type 1 or 2 Diabetes = 2 years • HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of PIT on endothelial function and renal failure;Secondary Objective: • impact of PIT on renal function parameters • impact of PIT on retinopathy • impact of PIT on neuropathy • impact of PIT on gylcemic control (HbA1c) • impact of PIT on Quality of Life • Demonstrate safety of PIT ;Primary end point(s): endothelial function renal failure;Timepoint(s) of evaluation of this end point: endothelial function (Visit 2, 6, 10, and 14) renal failure (Visit 2 and 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline (V2) to endpoint (V14) in Laboratory parameters for renal function (GFR, creatinine, proteinurea) - Sensory nerve function (pathtester, tuning fork) - Retinopathy assessment results (RetinaVue device) - HbA1c - Laboratory panel for insulin resistance and chronic systemic inflammation (glucose, RBP4,angiopoetin2, adiponectin, IL-6, hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin) - Quantitative mRNA expression of eNOS and MAPK - DTSQ questionnaire - Laboratory safety parameters ;Timepoint(s) of evaluation of this end point: Change from baseline (V2) to endpoint (V14) in Laboratory parameters for renal function (GFR, creatinine, proteinurea) (Visit 2 and 14) - Sensory nerve function (pathtester, tuning fork) (Visit 2, 6, 10, and 14) - Retinopathy assessment results (RetinaVue device) (Visit 2, 6, 10, and 14) - HbA1c (Visit 2 and 14) - Laboratory panel for insulin resistance and chronic systemic inflammation (glucose, RBP4,angiopoetin2, adiponectin, IL-6, hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin) (Visit 2 and 14) - Quantitative mRNA expression of eNOS and MAPK (Visit 2 and 14) - DTSQ questionnaire (Visit 2 and 14) - Laboratory safety parameters (Visit 2 and 14) | — |
Countries
Germany, United States
Contacts
Public ContactPresident of IDTS
Innovative Diabetes Treatments Studies LLC.
Outcome results
None listed