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Dapagliflozin for Type 2 Diabetes
Study Summary
This trial will help researchers understand how the body responds to having glucose in the urine, which could lead to better treatments for diabetes.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your body mass index (BMI) is between 25 and 35.People with normal blood sugar levels.People with type 2 diabetes are not allowed to participate.Your weight has not changed much in the last three months and you do not do very intense exercise.You are taking medications that can affect how your body processes sugar, except for metformin and sulfonylurea.You have severe diabetic eye disease, high levels of creatinine in your blood, or high levels of protein in your urine.If you have diabetes, you must have been taking the same dose of metformin and/or a sulfonylurea for at least 3 months.If you have diabetes, your HbA1c level should be less than 8.0%.
- Group 1: T2DM individuals on Dapagliflozin
- Group 2: T2DM individuals on Placebo
- Group 3: Normal Glucose Tolerance (NGT) on Dapagliflozin
- Group 4: Normal Glucose Tolerance (NGT) Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What potential risks does Normal Glucose Tolerance pose to individuals?
"There is sufficient proof of Normal Glucose Tolerance's safety, so it received an assessment score of 3."
Is the age limit for participants in this trial older than thirty years?
"This research study is open to individuals who are between 18 and 70 years old."
Is this research endeavor actively looking for participants?
"This particular study is no longer recruiting participants, as the trial was initially posted on May 23rd 2019 and last amended August 5th 2022. If you are seeking alternatives, 788 studies for diabetes mellitus type 2 and 63 trials for Normal Glucose Tolerance (NGT) are presently in search of volunteers."
What are the desired outcomes of this experiment?
"As declared by the trial's sponsor, AstraZeneca, the key success metric of this research will be Endogenous Glucose Production NGT subjects - dapa which is measured over a 3 week period. Additionally, other objectives include Renal Glucose Production T2DM subjects - dapa (Renal Glucose Production T2DMs after administering dapagliflozin), Renal Glucose Production NGT subjects - placebo(Renal Glucose Production NGTs post-placebo exposure) and Renal Glucose Producton NGT subjectd - DAPA (Renel G"
Could you explain the purpose of performing Normal Glucose Tolerance (NGT) tests?
"Normal Glucose Tolerance (NGT) can be managed through pharmaceuticals, dietary modifications, and physical activity."
What demographic is accepted in this clinical experiment?
"To successfully join this diabetes trial, the individual must suffer from type 2 diabetes mellitus and fall between 18-70 years old. Only 36 candidates will be enrolled in total."
What is the aggregate size of this medical experiment's participant population?
"Currently, this clinical trial is not enrolling any patients. First posted on May 23rd 2019 and last updated August 5th 2022, those looking for alternative studies may be pleased to know that there are 788 trials recruiting participants with diabetes mellitus type 2, and 63 studies actively admitting individuals with Normal Glucose Tolerance (NGT)."
Does this research have any peers or precedents?
"Currently, 63 trials related to Normal Glucose Tolerance (NGT) are being conducted in 235 cities and 50 countries. The first of these studies was hosted by AstraZeneca in 2014 and featured 700 participants until it reached its final drug approval stage. Subsequently, 18457 investigations have been carried out over the past 6 years."
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