Diabetes Mellitus, Type 2Phase 4NCT04030091
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
A Phase 4 study testing 3 hours humulin R 100 IU/mL PIT and 2 hours humulin R 100 IU/mL PIT in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Sciema UG at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- 3 hours humulin R 100 IU/mL PIT and 2 hours humulin R 100 IU/mL PIT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Sep 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, 55128
About this study
Official title: Pilot Study for Evaluation of the Impact of Pulsatile Insulin Infusion Therapy on Vascular Function in Patients With Type 1 and Type 2 Diabetes Mellitus
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
Read the 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 HbA1c and safety parameters. A point of care treatment (POCT) pregnancy test will be conducted in women of childbearing age. Patient demographics and history will be collected and a physical examination will be performed. The patient will complete a QoL, the continous glucose monitoring (CGM) sensor will be placed and trained, and the schedules for the subsequent treatment visits will be made. Also, the randomization (2 h vs 3 h) will be performed.
During the initiation visit , a series of clinical assessments will be made to document the patient status with respect to secondary complications: sensory nerve perception thresholds (tuning fork and path tester), retinopathy (RetinaVue camera). An ECG will be conducted, and blood will be drawn for assessment of the efficacy parameters. Thereafter the pulsatile insulin infusion therapy (PIT) procedure will be initiated.
For each 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 (manufacturer: endothelix). 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.
During all consecutive treatment visits the patient will arrive at the investigational site at the agreed time-point and information regarding potential adverse events will be collected. Vital signs will be measured and the PIT procedure will be performed as described. At visits V6 and V10 additional examinations (assessments of neuropathy and retinopathy, blood draws for efficacy parameters, diabetes treatment satifaction questionnaire (DTSQ) questionnaire) will be performed.
During the final Visit the assessments from baseline (ECG, physical examination, neuropathy assessments, retinopathy assessment, blood draws for all safety and efficacy parameters incl. messenger ribonucleic acid (mRNA) analysis) will be repeated. The patient will complete a final DTSQ questionnaire, which concludes the participation in the trial.
- Being tested
- 3 hours humulin R 100 IU/mL PIT, 2 hours humulin R 100 IU/mL PIT
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 hours humulin R 100 IU/mL PITDrug
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.
2 hours humulin R 100 IU/mL PITDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 2 hours humulin R 100 IU/mL PIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Impact of PIT on endothelial function before and one hour after the PIT initiation measured with the Vendys2 device
Measured: 1 hour
Secondary outcomes (6)
Renal function
It will be assessed whether insulin resistance has improved or worsened over the course of the study.
Measured laboratory parameters for renal function (GFR, creatinine, proteinurea)
Measured: 13 weeks
nerve function
Sensory nerve function (pathtester, tuning fork). It will be assessed whether insulin resistance has improved or worsened over the course of the study.
Measured: 13 weeks
Retinopathy
Retinopathy will be measured with the RetinaVue device. It will be assessed whether Retinopathy has improved or worsened over the course of the study.
Measured: 13 weeks
HbA1c
metabolic control
Measured: 13 weeks
Insulin resistance
For assessment of insulin resistance glucose, retinol-binding protein 4 (RBP4), angiopoetin2, adiponectin, interleukin 6 (IL-6), hsCRP, glucagon, insulin, c-peptide, and intact Proinsulin will be measured. Finally, it is assessed whether insulin resistance has improved or worsened over the course of the study.
Measured: 13 weeks
Diabetes treatment satisfaction questionnaire
Eight questions about the patient´s satisfaction with the diabetes treatment. Answer possibilities range form 1 (very good) to 10 (very bad)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start6 Sep 2019
- Primary completion19 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 arm of 2 hours pulsatile insulin infusion treatment vs. a second arm of 3 hours pulsatile insulin infusion treatment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Diabetes Treatment Studies LLC.
- Responsible party
- Sponsor
- Investigators
- Andreas Pfuetzner, Prof. Dr. Dr., Principal investigator, Pfützner Science & Health Institute GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030091
- Sponsor's protocol ID
- DCTI-PIT-001
- Status last verified
- Mar 2021
- First submitted
- 15 Jul 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of the Impact of Pulsatile Insulin Infusion Therapy on Vascular Function in Patients With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04030091
- Acronym / sponsor ID
- DCTI-PIT-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Collaborators
- Innovative Diabetes Treatment Studies LLC.
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 HbA1c and safety parameters. A point of care treatment (POCT) pregnancy test will be conducted in women of childbearing age. Patient demographics and history will be collected and a physical examination will be performed. The patient will complete a QoL, the continous glucose monitoring (CGM) sensor will be placed and trained, and the schedules for the subsequent treatment visits will be made. Also, the randomization (2 h vs 3 h) will be performed.
During the initiation visit , a series of clinical assessments will be made to document the patient status with respect to secondary complications: sensory nerve perception thresholds (tuning fork and path tester), retinopathy (RetinaVue camera). An ECG will be conducted, and blood will be drawn for assessment of the efficacy parameters. Thereafter the pulsatile insulin infusion therapy (PIT) procedure will be initiated.
For each 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 (manufacturer: endothelix). 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.
During all consecutive treatment visits the patient will arrive at the investigational site at the agreed time-point and information regarding potential adverse events will be collected. Vital signs will be measured and the PIT procedure will be performed as described. At visits V6 and V10 additional examinations (assessments of neuropathy and retinopathy, blood draws for efficacy parameters, diabetes treatment satifaction questionnaire (DTSQ) questionnaire) will be performed.
During the final Visit the assessments from baseline (ECG, physical examination, neuropathy assessments, retinopathy assessment, blood draws for all safety and efficacy parameters incl. messenger ribonucleic acid (mRNA) analysis) will be repeated. The patient will complete a final DTSQ questionnaire, which concludes the participation in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 arm of 2 hours pulsatile insulin infusion treatment vs. a second arm of 3 hours pulsatile insulin infusion treatment.
| Arm | Type | Receives |
|---|---|---|
| 3 hour pulsatile normal insulin infusion treatment | Experimental | Drug: 3 hours humulin R 100 IU/mL PITthe 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 |
| 2 hour pulsatile normal insulin infusion treatment | Experimental | Drug: 2 hours humulin R 100 IU/mL PITthe 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 hours humulin R 100 IU/mL PITPIT 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. | Drug | 3 hour pulsatile normal insulin infusion treatment |
| 2 hours humulin R 100 IU/mL PITAs 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. | Drug | 2 hour pulsatile normal insulin infusion treatment |
Primary outcome
Endothelial function
Time frame: 1 hour
Impact of PIT on endothelial function before and one hour after the PIT initiation measured with the Vendys2 device
6 secondary outcomes
Renal function
Time frame: 13 weeks
nerve function
Time frame: 13 weeks
Retinopathy
Time frame: 13 weeks
HbA1c
Time frame: 13 weeks
Insulin resistance
Time frame: 13 weeks
Diabetes treatment satisfaction questionnaire
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Pfuetzner, Prof. Dr. Dr. principal investigator
Pfützner Science & Health Institute GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3 hours humulin R 100 IU/mL PIT and 2 hours humulin R 100 IU/mL PIT in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Sciema UG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.