Not recruiting

Study on Insulin Aspart for Recovery from Low Blood Sugar in People with and without Type 2 Diabetes

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 Diabetes Mellitus, a condition where the body struggles to regulate blood sugar levels. The study will use a medication called insulin aspart, which is a type of insulin used to help control blood sugar levels. Insulin is a hormone that helps the body use sugar for energy and keeps blood sugar levels from getting too high.

The purpose of the study is to explore how different doses of insulin affect blood sugar levels in people with and without diabetes. Participants will receive insulin aspart through an injection, and the study will monitor how quickly their blood sugar levels return to normal after being lowered. This process is known as a "hypoglycemic clamp procedure," which is a method used to study how the body responds to low blood sugar levels.

During the study, participants will have their blood sugar levels carefully controlled and monitored. The study will compare the insulin doses needed to lower blood sugar levels in people with diabetes to those without diabetes. It will also look at how quickly participants recover from low blood sugar levels. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the insulin aspart. The study aims to provide valuable information on how insulin aspart can be used to manage blood sugar levels effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, participants will attend an initial visit. During this visit, a healthcare professional will explain the study procedures and answer any questions.
Participants will be asked to provide informed consent, confirming their understanding and willingness to participate in the study.
Step 2
Baseline assessment
Participants will undergo a baseline assessment, which includes a review of medical history, a physical examination, and laboratory tests to ensure eligibility.
Venous access will be established to allow for blood sampling as per the study protocol.
Step 3
First clamp visit
Participants will attend the first clamp visit, where the study procedure will be conducted.
A solution containing insulin aspart will be administered through an intravenous infusion to lower blood sugar levels to a specific target range.
The insulin dose required to lower blood sugar from 90 to 70 mg/dL and from 70 to 48 mg/dL will be measured.
Step 4
Monitoring and recovery
Participants will be closely monitored for signs of low blood sugar (hypoglycemia) and their ability to recover spontaneously will be assessed.
If necessary, glucose will be administered intravenously to assist in recovery.
Step 5
Second clamp visit
Participants will attend a second clamp visit, where the procedure will be repeated to compare results with the first visit.
The total amount of insulin required to achieve the target blood sugar level will be compared between the two visits.
Step 6
Follow-up
After completing the study procedures, participants will have a follow-up visit to ensure their well-being and to discuss any further questions or concerns.
The study team will review the results and provide feedback to the participants.

Who can join the trial?

14 criteria

Participant must be between 18 and 64 years old.
For those with Type 2 Diabetes:
- Must have been diagnosed for at least 6 months.
- Should be managing diabetes with diet, exercise, and stable treatment with metformin, with or without other allowed medications, for at least 3 months.
- Must have a HbA1c (a measure of blood sugar levels over time) of 9.5% or lower.
- For those without diabetes:
  - Must be considered healthy based on medical history and physical examination.
  - Must have good venous access for blood sampling.
  - Laboratory test results should be within normal range or have acceptable deviations that are not significant.
  - Body Mass Index (BMI, a measure of body fat based on height and weight) should be:
    
    Between 25.0 and 45.0 for those with diabetes.
    Between 25.0 and 29.9 for those without diabetes.
    Must have a stable body weight with less than 5% change in the last 3 months.
    Agree not to start an intensive diet or exercise program aimed at losing weight during the study.
    Women who can become pregnant must use highly effective birth control methods, stable for at least 2 months before the study.
    Must be able to give signed informed consent, agreeing to follow the study requirements and procedures.
    Must be reliable and willing to participate for the entire duration of the study.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to any of the study medications.
Patients who are currently pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have had a major surgery within the past 3 months.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients with severe liver disease.
Patients with a history of heart attack or stroke within the past 6 months.

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Verified sites

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Verified
Medical University Of Graz
Graz, Austria

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Investigated drugs

Insulin is a hormone that helps control blood sugar levels. In this study, insulin is used to lower blood sugar to specific levels. The researchers want to see how much insulin is needed to bring blood sugar down to certain points. This helps them understand how the body responds to insulin and how quickly it can recover from low blood sugar.

Insulin Aspart

What is already known about the treatment

Insulin – Insulin is administered through injections or an insulin pump to help manage blood sugar levels in people with diabetes. It is a well-established treatment in medicine, widely discussed in medical literature, particularly for managing Type 2 Diabetes Mellitus. The main therapeutic use of insulin is to lower blood sugar levels in individuals whose bodies do not produce enough insulin naturally. At the molecular level, insulin helps cells in the body absorb glucose from the bloodstream, reducing blood sugar levels. It is classified as a hormone and is essential for regulating blood sugar.

Investigated diseases

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with mild symptoms or none at all. As the condition progresses, individuals may experience increased thirst, frequent urination, hunger, fatigue, and blurred vision. Management of blood sugar levels is crucial to prevent further progression and complications.