Type 2 DiabetesPhase 2NCT02148250
PK/PD Study of U-500 Regular Insulin
A Phase 2 study testing U-500 insulin, 100 syringe units and U-500 insulin, 200 syringe units in people with Type 2 Diabetes and Insulin Resistance, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance, High Insulin Requirements
- What is being tested?
- U-500 insulin, 100 syringe units and U-500 insulin, 200 syringe units
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Duration of Action and Peak Effect of High Dose of U-500 Regular Insulin In Severly Insulin Resistant Subjects With Type 2 Diabetes Mellitus
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.
Read the 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.
- Being tested
- U-500 insulin, 100 syringe units, U-500 insulin, 200 syringe units
- Keywords
- Type 2 diabetes, Insulin resistance, High insulin requirements, U 500
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-500 insulin, 100 syringe unitsDrug
Also called Highly concentrated regular insulin
Subjects are randomized to receive 100 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
U-500 insulin, 200 syringe unitsDrug
Also called Highly concentrated regular insulin
Subjects are randomized to receive 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 100 Syringe Units, then 200 | Experimental | Participants randomized to first receive 100 syringe units of U-500 regular insulin, then 200 units Receives: 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 Receives: Drug: U-500 insulin, 100 syringe units; Drug: U-500 insulin, 200 syringe units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration (in Hours) of 20 % Dextrose Infusion Requirement
Measured: 24 hours post insulin injection
Secondary outcomes (4)
Peak Infusion Rate Achieved After U-500
Measured: 4 hours after insulin injection
Total Glucose Given After U-500 Dose
Measured: 4 hours
Time Following Injection the Glucose Infusion Was Started to Maintain EU
Measured: 24 hours
Total Glucose Required to Maintain Euglycaemia
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Elizabeth Seaquist, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148250
- Sponsor's protocol ID
- 1404M49843
- Status last verified
- Jan 2020
- First submitted
- 22 May 2014
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Action and Peak Effect of High Dose of U-500 Regular Insulin In Severly Insulin Resistant Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02148250
- Acronym / sponsor ID
- 1404M49843
- Keywords
- Type 2 diabetes, Insulin resistance, High insulin requirements, U 500
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 Syringe Units, then 200 | Experimental | Drug: U-500 insulin, 100 syringe units, Drug: U-500 insulin, 200 syringe unitsParticipants randomized to first receive 100 syringe units of U-500 regular insulin, then 200 units |
| 200 Syringe Units, then 100 | Experimental | Drug: U-500 insulin, 100 syringe units, Drug: U-500 insulin, 200 syringe unitsParticipants randomized to first receive 200 syringe units of U-500 regular insulin, then 100 units |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- • On systemic corticosteroids in preceding 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U-500 insulin, 100 syringe unitsAlso: Highly concentrated regular insulinSubjects are randomized to receive 100 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks. | Drug | 100 Syringe Units, then 200, 200 Syringe Units, then 100 |
| U-500 insulin, 200 syringe unitsAlso: Highly concentrated regular insulinSubjects are randomized to receive 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks. | Drug | 100 Syringe Units, then 200, 200 Syringe Units, then 100 |
Primary outcome
Duration (in Hours) of 20 % Dextrose Infusion Requirement
Time frame: 24 hours post insulin injection
4 secondary outcomes
Peak Infusion Rate Achieved After U-500
Time frame: 4 hours after insulin injection
Total Glucose Given After U-500 Dose
Time frame: 4 hours
Time Following Injection the Glucose Infusion Was Started to Maintain EU
Time frame: 24 hours
Total Glucose Required to Maintain Euglycaemia
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Seaquist, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing U-500 insulin, 100 syringe units and U-500 insulin, 200 syringe units in people with Type 2 Diabetes and Insulin Resistance, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (in Hours) of 20 % Dextrose Infusion Requirement (time frame: 24 hours post insulin injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.