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

NCT04030091 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: DCTI-PIT-001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Impact of PIT on endothelial function before and one hour after the PIT initiation measured with the Vendys2 device

  1 hour

Secondary Outcomes (6)

• Renal function

  13 weeks

• nerve function

  13 weeks

• Retinopathy

  13 weeks

• HbA1c

  13 weeks

• Insulin resistance

  13 weeks

Study Arms (2)

3 hour pulsatile normal insulin infusion treatment

EXPERIMENTAL

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

Drug: 3 hours humulin R 100 IU/mL PIT

2 hour pulsatile normal insulin infusion treatment

EXPERIMENTAL

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

Drug: 2 hours humulin R 100 IU/mL PIT

Interventions

3 hours humulin R 100 IU/mL PIT DRUG

PIT procedure: a venous catheter will be placed into one superficial vein at one arm, which will be connected to the insulin infusion pump and a glucose infusion pump via a three-way connector. Endothelial function will be measured by means of the Vendys 2 device. The blood glucose will be tested by means of a POCT meter and the CGM, and the PIT procedure will be started (10 pulses of 3 U of regular human insulin per hour). Blood glucose will be tested every 5 to 10 min and glucose infusion will be started once a drop in blood glucose is detected. Adjustment of glucose administration will be performed until a stable glucose value between 80 mg/dL to 160 mg/dL is reached. In parallel, endothelial function will be measured every 30 min. At the end of the PIT procedure, the venous catheter will be removed and the patient will be discharged until the next visit.

3 hour pulsatile normal insulin infusion treatment

2 hours humulin R 100 IU/mL PIT DRUG

As described for the Intervention "3 hours of pulsatile insulin infusion (PIT) with humulin R 100 IU/mL", the treatment duration is just one hour less.

2 hour pulsatile normal insulin infusion treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Sciema UG: lead
• Innovative Diabetes Treatment Studies LLC.: collaborator

Study Sites (2)

NYC Research, Inc.

New York, New York, 10455, United States

Location

Pfützner Science & Health Institute GmbH

Mainz, Rhineland-Palatinate, 55128, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andreas Pfuetzner, Prof. Dr. Dr.

  Pfützner Science & Health Institute GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 arm of 2 hours pulsatile insulin infusion treatment vs. a second arm of 3 hours pulsatile insulin infusion treatment.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 23, 2019
• Study Start: September 6, 2019
• Primary Completion: October 19, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

DE (1); US (1)