Evaluating the Benefits of Physiologic Insulin Delivery

NCT04416737 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: IRB-570321K23DK122017
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Insulin Maximum Concentration in Plasma

  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

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

• Time Until Maximum Insulin Concentration in Plasma

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

Study Arms (2)

Upper Peritoneal, then Lower Peritoneal, then Subcutaneous

EXPERIMENTAL

Ultra-fast acting insulin will be injected into the upper peritoneum then lower peritoneum then subcutaneous space.

Drug: Ultra-rapid insulin

Lower Peritoneal, then Upper Peritoneal, then Subcutaneous

EXPERIMENTAL

Ultra-fast acting insulin will be injected into the lower peritoneum then upper peritoneum then subcutaneous space.

Drug: Ultra-rapid insulin

Interventions

Ultra-rapid insulin DRUG

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.

Lower Peritoneal, then Upper Peritoneal, then Subcutaneous; Upper Peritoneal, then Lower Peritoneal, then Subcutaneous

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Clinical diagnosis of type 1 diabetes
• On insulin pump therapy and continuous glucose monitor (CGM) for at least 3 months
• Ability to safely receive intraperitoneal injection
• For females, not currently known to be pregnant
• Understanding and willingness to follow the protocol and sign informed consent
• Ability to speak, read and write in the language of the investigators

You may not qualify if:

• Diabetic ketoacidosis in the past 3 months
• Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
• Pregnant or lactating
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• Known cardiovascular events in the last 6 months
• Known seizure disorder
• Inpatient psychiatric treatment in the past 6 months
• Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
• Suspected drug or alcohol abuse
• Chronic kidney disease (GFR \< 60 mL/min/1.73m\^2)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rayhan Lal
• Organization: Stanford University

inforay@stanford.edu

650-725-2908

Study Officials

• Rayhan Lal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Med+Peds Endocrinologist

Model Details: Participants will each come in for 3 visits separated by at least 1 week. During the first two visits they will be randomized to either upper or lower peritoneal injection followed by the other site. During the third visit a subcutaneous injection will be performed to provide comparative data to the standard of care.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: November 1, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)