A Phase 1 interventional study of Ultra-rapid insulin in Type 1 Diabetes, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Stanford University · Phase 1, Interventional, and Other
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.
The eventual goal of this line of work is an implanted insulin pump that delivers insulin automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal pharmacokinetic studies used only concentrated regular insulin, which may be too slow to provide full closed-loop insulin delivery without meal announcement. A description of intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of glucagon response in longstanding diabetes and clearance of insulin by the liver, both of which could provide hypoglycemic rescue in automated insulin delivery systems.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.
Drug: Ultra-rapid insulin
Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.
Drug: Ultra-rapid insulin
Following 0.5-3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.
Glucagon Response to Induced Hypoglycemia
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.
Time frame: Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Insulin Maximum Concentration in Plasma
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).
Time frame: 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
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 frame: Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
Time Until Maximum Insulin Concentration in Plasma
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).
Time frame: Peritoneal: Every 5 minutes for 180 minutes max; Subcutaneous: Every 15 minutes for 360 minutes max
| Milestone | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous |
|---|---|---|
| Started | 10 | 6 |
| Received injection | 10 | 6 |
| Received disallowed medication prior to injection | 0 | 1 |
| Suspension of basal insulin > 2 hours prior to injection | 1 | 1 |
| Achieved induced hypoglycemia | 4 | 4 |
| Completed | 10 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Milestone | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous |
|---|---|---|
| Started | 10 | 5 |
| Suspension of basal insulin > 2 hours prior to injection | 1 | 1 |
| Achieved induced hypoglycemia | 7 | 4 |
| Completed | 10 | 5 |
| Not completed | 0 | 0 |
| Milestone | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous |
|---|---|---|
| Started | 10 | 5 |
| Suspension of basal insulin > 2 hours prior to injection | 1 | 1 |
| Achieved induced hypoglycemia | 9 | 4 |
| Completed | 10 | 5 |
| Not completed | 0 | 0 |
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.
| pg/mL | Upper Peritoneal Injection | Lower Peritoneal Injection | Injection- All Peritoneal | Subcutaneous Injection |
|---|---|---|---|---|
| Glucagon Response to Induced Hypoglycemia | 4.8 (2.7 to 8.2) | 8.8 (3.4 to 12.8) | 5.8 (3.0 to 9.1) | 4.2 (2.3 to 6.3) |
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).
| mU/L | Upper Peritoneal Injection | Lower Peritoneal Injection | Injection- All Peritoneal | Subcutaneous Injection |
|---|---|---|---|---|
| Insulin Maximum Concentration in Plasma | 56.81 (46.40 to 63.49) | 63.26 (37.60 to 78.84) | 56.95 (44.01 to 77.57) | 57.47 (46.84 to 69.53) |
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).
| Treatments | Upper Peritoneal Injection | Lower Peritoneal Injection | Peritoneal Injection | Subcutaneous Injection |
|---|---|---|---|---|
| Hypoglycemic Treatments Required as a Measure of Glucose Values | 1 (0 to 2) | 1 (1 to 1) | 1 (0 to 1) | 3 (3 to 4) |
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).
| minutes | Upper Peritoneal Injection | Lower Peritoneal Injection | Injection- All Peritoneal | Subcutaneous Injection |
|---|---|---|---|---|
| Time Until Maximum Insulin Concentration in Plasma | 35 (25 to 40) | 25 (20 to 40) | 30 (20 to 40) | 60 (45 to 75) |
Collected over Average approximately 2 months (may have been up to 13 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Upper Peritoneal Injection | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Lower Peritoneal Injection | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Subcutaneous Injection | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous | Total |
|---|---|---|---|
| Mean | 39.0 ± 7.1 | 38.8 ± 11.7 | 38.9 ± 10 |
| Sex: Female, Male(Participants) | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 4 | 2 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 10 | 4 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 5 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Upper Peritoneal, Then Lower Peritoneal, Then Subcutaneous | Lower Peritoneal, Then Upper Peritoneal, Then Subcutaneous | Total |
|---|---|---|---|
| United States | 10 | 6 | 16 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No current plan
Ran from Nov 2021 to primary completion in Jun 2023, 19 months.
Results were first posted in Oct 2024, 1 year 3 months after primary completion.
Of 58 non-industry phase 1 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's 19 months is below that.
Counting every sponsor, half of 155 studies reached it within 12 months; a quarter within 5 and three quarters within 32.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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