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Insulin

3 hour pulsatile normal insulin infusion treatment for Diabetes

Phase 4
Waitlist Available
Led By Andreas Pfuetzner, Prof. Dr. Dr.
Research Sponsored by Sciema UG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

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

Eligible Conditions
  • Diabetes
  • Type 2 Diabetes
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endothelial function
Secondary study objectives
Diabetes treatment satisfaction questionnaire
HbA1c
Insulin resistance
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 3 hour pulsatile normal insulin infusion treatmentExperimental Treatment1 Intervention
the pulsatile insulin infusion treatment will be applied for 3 hours once a week with 10 pulses of 3 U of humulin R 100 IU/mL insulin per hour
Group II: 2 hour pulsatile normal insulin infusion treatmentExperimental Treatment1 Intervention
the pulsatile insulin infusion treatment will be applied for 2 hours once a week with 10 pulses of 3 U of humulin R 100 IU/mL insulin per hour
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

Sciema UGLead Sponsor
7 Previous Clinical Trials
1,084 Total Patients Enrolled
Innovative Diabetes Treatment Studies LLC.UNKNOWN
1 Previous Clinical Trials
9 Total Patients Enrolled
Andreas Pfuetzner, Prof. Dr. Dr.Principal InvestigatorPfützner Science & Health Institute GmbH
~4 spots leftby Nov 2025
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