- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148250
PK/PD Study of U-500 Regular Insulin
Duration of Action and Peak Effect of High Dose of U-500 Regular Insulin In Severly Insulin Resistant Subjects With Type 2 Diabetes Mellitus
Study Overview
Status
Intervention / Treatment
Detailed Description
How the Study is performed:
If you agree to participate, you will be given the chance to come to the Masonic Clinical Research Unit (MCRU) at the University of Minnesota for a tour of the facility in the days before the actual experiment. While at the MCRU, one of the investigators will talk with you about the study and provide you with information about the experiments.
During the week before the study, you will be asked to hold oral or injectable non-insulin medicines used to treat diabetes for 1 week prior to the study and to avoid exercise 48 hours prior to the study. During this time you will be asked to monitor your blood sugars and call the investigators for help in managing your sugars if they go outside of the target recommended by your doctor.
On night before the study starts, you will be asked to come to Masonic Clinical Research Unit (MCRU) after dinner (between 8-10 PM). Upon your arrival two catheters will be placed in the arms to establish intravenous access. One will be used for subsequent blood sampling and the other will be used for infusion. We will administer intravenous insulin as necessary to maintain blood glucose between 100-150 mg/dL overnight. Blood sugars will be obtained every 15-60 minutes overnight to ensure the glucose remains at target. At 7 AM the next morning, the intravenous insulin will be stopped. The study will the start when by giving you a dose of either 100 or 200 units of U-500 regular insulin subcutaneously in random order (like a flip of a coin). Since insulin drops the blood sugar, we will also be ready to start an intravenous infusion of glucose to maintain your blood sugars at 100 mg/dl. To keep your sugar at this target, blood will be collected every 15-60 minutes to measure blood sugar and the information will be used by the investigators to figure out how much glucose to give you. We will continue to measure blood glucose until you can maintain blood glucose without a glucose infusion for at least 10 hours or start to experience hyperglycemia (BG > 150 mg/dl) for two hours after discontinuation of the glucose infusion. At that point, the catheters will be removed and you will be discharged to home. During your stay at the MCRU, carbohydrate free meals will be provided starting at noon and continued at traditional mealtimes thereafter for the duration of the glucose infusion. Non-caloric decaffeinated beverages will be available as needed. At the completion of the study you will be told to resume your usual diabetes medications.
Two to four weeks later, you will be asked to once again hold oral or injectable non-insulin medicines used to treat diabetes for 1 week prior to the second part of the study and to avoid exercise 48 hours prior to the study. During this time you will be again asked to monitor your blood sugars and call the investigators for help in managing your sugars if they go outside of the target recommended by your doctor. On night before the second part of the study starts, you will be asked to come to Masonic Clinical Research Unit (MCRU) after dinner. Intravenous lines will again be placed, intravenous insulin will again be given overnight to keep your blood sugar between 100-150 mg/dl, and in the morning you will be given the dose of U500 regular insulin you did not receive during the first visit. Your blood sugar will then be maintained at 100 mg/dl by the infusion of glucose. We will continue to measure blood glucose every 15-60 minutes until you can maintain blood glucose without a glucose infusion for at least 10 hours or start to experience hyperglycemia (BG > 150 mg/dl) for two hours after discontinuation of the glucose infusion. You will be fed the same diet as during your first visit and will be told to resume your diabetes medications at the time we send you home.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 100 Syringe Units, then 200
Participants randomized to first receive 100 syringe units of U-500 regular insulin, then 200 units
|
Subjects are randomized to receive 100 syringe units of U-500 insulin.
Subjects will receive opposite treatment after 4-8 weeks.
Other Names:
Subjects are randomized to receive 200 syringe units of U-500 insulin.
Subjects will receive opposite treatment after 4-8 weeks.
Other Names:
|
EXPERIMENTAL: 200 Syringe Units, then 100
Participants randomized to first receive 200 syringe units of U-500 regular insulin, then 100 units
|
Subjects are randomized to receive 100 syringe units of U-500 insulin.
Subjects will receive opposite treatment after 4-8 weeks.
Other Names:
Subjects are randomized to receive 200 syringe units of U-500 insulin.
Subjects will receive opposite treatment after 4-8 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration (in Hours) of 20 % Dextrose Infusion Requirement
Time Frame: 24 hours post insulin injection
|
24 hours post insulin injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak Infusion Rate Achieved After U-500
Time Frame: 4 hours after insulin injection
|
4 hours after insulin injection
|
Total Glucose Given After U-500 Dose
Time Frame: 4 hours
|
4 hours
|
Time Following Injection the Glucose Infusion Was Started to Maintain EU
Time Frame: 24 hours
|
24 hours
|
Total Glucose Required to Maintain Euglycaemia
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1404M49843
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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