Trial · Interventional

CompletedPhase 1Results postedRegistry data

Evaluating the Benefits of Physiologic Insulin Delivery

NCTNCT04416737Other idIRB-57032Other id1K23DK122017

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 1
Enrollment: 16 participants (actual)
Sponsor: Stanford University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Nov 2021
Primary completion: 2 Jun 2023
Completion: 2 Jun 2023
First posted: 4 Jun 2020
Last update posted: 1 Oct 2024
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 1
Evaluating the Benefits of Physiologic Insulin Delivery
NCT04416737
1 Nov 2021 to 2 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users. In the present study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under ultrasound guidance and compare it to subcutaneous injection. We will measure glucose, insulin and glucagon following these injections, to assess for benefits in counter-regulatory hormone production and insulin pharmacokinetics.

Interventions

Ultra-rapid insulinDrug

Arms2

Experimental
Upper Peritoneal, then Lower Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.
Experimental
Lower Peritoneal, then Upper Peritoneal, then Subcutaneous
Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.

Primary outcomes1

Outcomes the sponsor listed as primary.

Glucagon Response to Induced Hypoglycemia
Time frame · Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Registry description
For each injection site we will assess the peak concentration of glucagon at time of the first induced hypoglycemic nadir. Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal). Participants must have achieved induced hypoglycemia to be evaluable for the primary outcome.

Secondary outcomes(3)

Insulin Maximum Concentration in Plasma
Time frame · Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Registry description
We will assess the maximum concentration of circulating insulin for each injection site after a median injection of 40% of each participant's total daily dose (approximately 0.25 units per kilogram of body weight). Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal).
Hypoglycemic Treatments Required as a Measure of Glucose Values
Time frame · Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Registry description
We will compare the number of rescue treatments (2.5ml/kg 10% Dextrose) required to treat hypoglycemia \<50mg/dl for each injection location of approximately 0.25u/kg ultra-rapid insulin. Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal).
Time Until Maximum Insulin Concentration in Plasma
Time frame · Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Registry description
We will assess time until the maximum concentration of circulating insulin for each injection site after a median injection of 40% of each participant's total daily dose (approximately 0.25 units per kilogram of body weight). Analysis includes reporting groups for each type of injection, and upper and lower peritoneal injections combined (Injection- All Peritoneal).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Glucagon Response to Induced Hypoglycemia

Group	Value (pg/mL)
Upper Peritoneal Injection	4.8
Lower Peritoneal Injection	8.8
Injection- All Peritoneal	5.8
Subcutaneous Injection	4.2

Secondary and other outcome results(3)

Secondary outcomeMedian· Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Insulin Maximum Concentration in Plasma

Group	Value (mU/L)
Upper Peritoneal Injection	56.81
Lower Peritoneal Injection	63.26
Injection- All Peritoneal	56.95
Subcutaneous Injection	57.47

Secondary outcomeMedian· Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Hypoglycemic Treatments Required as a Measure of Glucose Values

Group	Value (Treatments)
Upper Peritoneal Injection	1
Lower Peritoneal Injection	1
Peritoneal Injection	1
Subcutaneous Injection	3

Secondary outcomeMedian· Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max

Time Until Maximum Insulin Concentration in Plasma

Group	Value (minutes)
Upper Peritoneal Injection	35
Lower Peritoneal Injection	25
Injection- All Peritoneal	30
Subcutaneous Injection	60

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Upper Peritoneal InjectionUltra-fast acting insulin injected into the upper peritoneum	0 / 15	0 / 15	0 / 15
Lower Peritoneal InjectionUltra-fast acting insulin injected into the lower peritoneum	0 / 16	0 / 16	0 / 16
Subcutaneous InjectionUltra-fast acting insulin injected subcutaneously	0 / 15	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. 18-60 years of age 2. Clinical diagnosis of type 1 diabetes 3. On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months 4. Ability to safely receive intraperitoneal injection 5. For females, not currently known to be pregnant 6. Understanding and willingness to follow the protocol and sign informed consent 7. Ability to speak, read and write in the language of the investigators Exclusion Criteria: 1. Diabetic ketoacidosis in the past 3 months 2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment 3. Pregnant or lactating 4. Active infection 5. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 6. Known cardiovascular events in the last 6 months 7. Known seizure disorder 8. Inpatient psychiatric treatment in the past 6 months 9. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication. 10. Suspected drug or alcohol abuse 11. Chronic kidney disease (GFR \< 60 mL/min/1.73m\^2)

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