PK/PD Study of U-500 Regular Insulin

NCT02148250 | Completed Phase 2 Results

• 1 other identifier: 1404M49843
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how U500 regular insulin can be effectively be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take U100 insulin, but if they require large doses (such as \>150 units a day) they may experience pain at this site of injection and the absorption of the insulin is unpredictable, thereby leading to poor glucose control. To overcome these problems, doctors sometimes switch to a more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume. However, how to best use U-500 insulin is not certain. The investigators are not really sure how long a given dose is effective in patients who require large doses (\>150 units of U100 insulin), so are not sure of how often the drug should be administered. In this study, the investigators will determine how effective two different doses of U-500 regular insulin (100 U and 200 U) are in lowering blood sugar and how long these two doses last. This information will help doctors develop better treatment plans for patients with type 2 diabetes.

Conditions

Type 2 Diabetes; Insulin Resistance; High Insulin Requirements

Keywords

Type 2 diabetes; Insulin resistance; High insulin requirements; U 500

Outcome Measures

Primary Outcomes (1)

• Duration (in Hours) of 20 % Dextrose Infusion Requirement

  24 hours post insulin injection

Secondary Outcomes (4)

• Peak Infusion Rate Achieved After U-500

  4 hours after insulin injection

• Total Glucose Given After U-500 Dose

  4 hours

• Time Following Injection the Glucose Infusion Was Started to Maintain EU

  24 hours

• Total Glucose Required to Maintain Euglycaemia

  24 hours

Study Arms (2)

100 Syringe Units, then 200

EXPERIMENTAL

Participants randomized to first receive 100 syringe units of U-500 regular insulin, then 200 units

Drug: U-500 insulin, 100 syringe units; Drug: U-500 insulin, 200 syringe units

200 Syringe Units, then 100

EXPERIMENTAL

Participants randomized to first receive 200 syringe units of U-500 regular insulin, then 100 units

Drug: U-500 insulin, 100 syringe units; Drug: U-500 insulin, 200 syringe units

Interventions

U-500 insulin, 100 syringe units DRUG

Subjects are randomized to receive 100 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.

Also known as: Highly concentrated regular insulin

100 Syringe Units, then 200; 200 Syringe Units, then 100

U-500 insulin, 200 syringe units DRUG

Subjects are randomized to receive 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.

Also known as: Highly concentrated regular insulin

100 Syringe Units, then 200; 200 Syringe Units, then 100

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Ages 30-65 years
• A1c between 7-9.5% within the past month
• On \>100 units of insulin per day
• Willing to discontinue oral/injectable non-insulin hypoglycemic agents for minimum of 1 week prior to study
• Willing to avoid exercise 48 hours prior to study
• Willing to be fasting for up to 24 hours
• BMI between 25 and 38 kg/m2

You may not qualify if:

• On systemic corticosteroids in preceding 3 months
• Heavy alcohol consumption (\>21 drinks/week men, \>14 drinks/week women)
• Unwillingness to stop alcohol consumption for 24 hours before each study visit
• Pregnant or actively trying to conceive
• Current diagnosis of active infection, cancer (other than basal cell carcinoma), vascular disease, organ failure
• Current transplant recipient

Sponsors & Collaborators

• University of Minnesota: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elizabth Seaquist, MD
• Organization: University of Minnesota

seaqu001@umn.edu

612-624-9176

Study Officials

• Elizabeth Seaquist, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 26, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-01

Locations

US (1)