USF Diabetes Center
USF Health

Research Studies

Type 2 Diabetes

Growth Hormone Research Studies


For More Information Contact:

Craig Bobik, MPH
(813) 396-2595
cbobik@health.usf.edu


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Research Studies

Type 1 Diabetes (T1D) Research Studies

T1D Exchange Clinical Registry

The T1D Exchange has a registry of more than 26,000 individuals with Type 1 Diabetes. The T1D Exchange registry and T1D Exchange studies will help us to learn more about Type 1 Diabetes to improve diabetes treatment, management, and care. Individuals with T1D joining one of the T1D Exchange studies will also be enrolled in the Registry.

Who can join?

People of any age with a clinical diagnosis of Type 1 Diabetes who are eligible for another research study through the Exchange are eligible for this study.

What will study participants be asked to do?

    • The Registry will collect information about your diabetes and your health that is recorded in your medical chart. In addition, you will complete a form with questions about your diabetes, health, and background.
    • There are no extra visits in beyond your usual clinic visits, and no blood tests or clinical procedures are required.
    • You also have the option to join Glu, a T1D Exchange social networking and data collection website. You do not have to be part of the T1D Exchange or the Registry to join Glu.
    • Please visit www.myglu.org to sign up today!

Why do we need YOU?

YOU are the expert on managing your diabetes day-to-day, so we want to learn from YOU.

We think your information, straight from you, is key to improving our understanding of T1D treatment and how it affects the person with diabetes and their family. We hope to learn whether some ways of managing T1D are better than other ways. Having information about a very large number of people with T1D together in one database will allow us to explore this information as never before.

Who is involved in this project?

More than 60 diabetes centers across the United States are participating in the T1D Exchange. In the future, it is hoped that centers in other countries will participate as well. The Jaeb Center for Health Research in Tampa is the coordinating center for the T1D Exchange and the Leona M. and Harry B. Helmsley Charitable Trust has provided the funding for the project.

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Severe Hypoglycemia in Older Adults with Type 1 Diabetes

Analysis of T1D Exchange Registry information has shown that severe low blood sugars (hypoglycemia) occur more commonly in older adults who have had T1D for many years. We are now doing a study to try to find out why this occurs in order to develop ways to prevent it.

Who can participate?

    • Adults 60 years of age and older
    • Those with Type 1 Diabetes for 20 years or more
    • Must have had a severe low blood sugar in the past 12 months OR must have had no severe lows in the past three years

What will study participants be asked to do?

Complete two study visits over the course of two to three weeks. If one of your study visits cannot be completed due to a low blood sugar you may have another visit to complete the study. During these visits, blood will be taken and several questionnaires will be completed. You will wear a continuous glucose monitor (CGM) for two weeks.

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Metformin Therapy for Overweight Adolescents with Type 1 Diabetes

The purpose of this research study is to find out if a medication called metformin can improve blood glucose control when taken in addition to insulin in overweight teenagers with T1D. Metformin is a pill that is used commonly in people with Type 2 Diabetes to lower blood sugar and help the body respond better to insulin. Taking part in the study may help researchers to understand how to improve blood sugar control people with Type 1 Diabetes that are overweight.

Who can participate?

    • Teenagers who are have had their 12th birthday but are not yet 20 years old
    • Those with Type 1 Diabetes for at least 1 year
    • Have a body mass index (BMI) that greater than or equal to that of 85 out of 100 teenagers their same age and sex.
    • Currently taking insulin by multiple daily injections or using an insulin pump

What will study participants be asked to do?

    • Half the people will take metformin pills
    • Half the people will take a placebo (pills that do not contain active drug)
    • You will not know whether your pills contain metformin or the placebo.

Teenagers in the study will be asked to come to the Diabetes Center for several study visits over about 6 months. During these visits, blood will be taken and information will be collected. They will be given the study medicine and related supplies as well as a glucose meter and glucose test strips.

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A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus (NN5401-3816)

The purpose of this study is to compare the blood sugar lowering effect and the safety of a newly developed insulin compared to long-acting Levemir® insulin, both in combination with rapid acting insulin as meal-time insulin when used to treat type 1 diabetes in children and teenagers.

Who can participate?

    • Children and Teenagers at least 1 year-old but not yet 18 years old
    • Those that have Type 1 Diabetes
    • Those that have needed insulin every day for at least 3 months (total dose of insulin: less than or equal to 2 units for every kilogram of their weight)

What will study participants be asked to do?

Participants will receive one of the following study insulins in combination with mealtime Novalog® insulin:

    • A newly developed mixed insulin that is a combination of a new long-acting insulin called degludec and Novalog®,

      OR

    • Long-acting Levemir® insulin

You will have nine visits to the Diabetes Center and at least 10 telephone calls over 18 weeks (4.5 months). Blood will be taken at five different clinic visits and other health information will be collected.

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T1D Exchange Clinical Registry: Residual C-Peptide Study

Would you like to know if your pancreas is still producing insulin?

Most Type 1 Diabetes (T1D) experts now believe that many people with long-standing T1D may still be able to produce small amounts of insulin. Proving that they can still make insulin may lead to future studies to reverse diabetes in those that already have it.

Who can join?

THIS STUDY IS NOT ACCEPTING NEW VOLUNTEERS.

What will study participants be asked to do?

    • The research study may have up to three visits. All blood tests that are part of the study will be done free of charge.
    • We will also provide you and your study doctor with some of the test results.

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TrialNet Natural History Study: A Pathway to Prevention

TrialNet is screening relatives of people with Type 1 Diabetes to find out if these family members are at risk for developing diabetes and to see if they might be qualified to participate in a prevention study. Through a simple blood test, we can detect markers in the blood, called autoantibodies, that indicate that the body's immune system has begun to attack the cells that make insulin. Relatives of people with T1D have about a 3-4 percent chance of testing positive for these autoantibodies associated with diabetes. If we learn you are at-risk, additional testing will be offered to better estimate your chances of developing Type 1 Diabetes. If you qualify, you may have an opportunity to be enrolled in either a Natural History or Prevention Study. All research volunteers will be followed closely for early detection of Type 1 Diabetes. Early detection of Type 1 Diabetes may improve your blood sugar control and reduce your chances of developing complications.

Who can participate?

    • Individuals who are 1-45 years of age with a parent, child, brother, or sister with Type 1 Diabetes
    • Individuals who are 1-20 years of age with a niece, nephew, aunt, uncle, grandparent, half-sibling or cousin with Type 1 Diabetes.
    • Note: A relative diagnosed before the age of 40 AND started on insulin within the first year of diagnosis probably has Type 1 Diabetes.

What will study participants be asked to do?

Screening involves a simple blood test for the presence of diabetes-related autoantibodies that may appear years before Type 1 Diabetes develops.

Those under the age of 18 can be rescreened every year up unitl their 18th birthday to watch for any change

THIS STUDY IS ACTIVELY RECRUITING!

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TrialNet: Oral Insulin Study

Results from a recently completed study (DPT-1) suggest that oral insulin (insulin taken by mouth, not by injection) might delay or prevent Type 1 Diabetes in some people found to be at risk. Oral insulin has no effect on blood sugar, but may reduce or stop the immune system's attack on the insulin producing beta-cells.TrialNet is now testing oral insulin to see whether or not it helps to delay or prevent Type 1 Diabetes.

Who can participate?

Screening to determine eligibility for this study is done through the TrialNet Natural History Study.

What will study participants be asked to do?

You will take one study capsule each day.

    • Half the people will take capsules filled with insulin
    • Half the people will take a placebo (capsules that contain an inactive ingredient)
    • You will not know whether your capsules contain insulin or placebo.

You will come to the Diabetes Center for blood test every 6 months and at other times as needed.

THIS STUDY IS ACTIVELY RECRUITING!

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TrialNet: Anti-CD3 Study

We want to see if an experimental medication called teplizumab may stop or slow down the autoimmune reaction that destroys the insulin-producing beta-cells in people who are at high risk of developing Type 1 Diabetes. This research study will compare people who get the experimental treatment with those who do not.

Who can participate?

Screening to determine who may qualify for this study is done through the TrialNet Natural History Study.

What will study participants be asked to do?

    • Half the people will get IV infusions of teplizumab.
    • Half the people will get IV infusions that look like teplizumab but have no active drug (placebo).
    • You and the researcher will not know if you are receiving teplizumab or placebo.

Blood tests will be done to examine the effects of teplizumab and to learn how it may work in people who are at risk for developing diabetes. Teplizumab treatment is given into a vein each day for 14 days.

THIS STUDY IS ACTIVELY RECRUITING!

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TrialNet: Long-Term Investigative Follow-Up (LIFT) Study

People who have participated in TrialNet prevention studies who later develop Type 1 Diabetes will be asked to join a long-term follow up study. The purpose of this study is to measure any long-term effects of being in a TrialNet study on their diabetes because of their earlier diagnosis and treatment of diabetes or from receiving a study drug.

Who can participate?

This study will follow subjects from the Natural History, Oral Insulin and Anti-CD3 studies who develop Type 1 Diabetes.

What will study participants be asked to do?

Those joining the study will be asked to come to visits every 6 months for those still making insulin and once a year for those who are not.

THIS STUDY IS ACTIVELY RECRUITING!

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TrialNet: Dried Blood Spot (DBS) Sub-Study

TrialNet is a research group dedicated to the study, prevention, and early treatment of Type 1 Diabetes. This study will help us learn more about another way to do blood testing for autoantibodies to determine risk for Type 1 Diabetes.

Who can participate?

    • People participating in the Screening or Monitoring Phases of the TrialNet Natural History Pathway to Prevention Study.

What will study participants be asked to do?

    • Provide a capillary (fingertip) blood sample in addition to the sample taken from a vein obtained for the Pathway to Prevention Study. The fingertip sample must fill five 1.5cm diameter spots on a filter paper card.
    • The participant and/or their families will be asked to complete a questionnaire to find out how they feel about the two methods of sample collection.

THIS STUDY IS ACTIVELY RECRUITING!

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TrialNet: Abatacept Study

The goal of this study is to learn if abatacept helps delay or prevent the development of Type 1 Diabetes in people who have relatives with this disease and who show added risk.

Who can participate?

Screening to determine who can join this study is done through the TrialNet Natural History Pathway to Prevention Study.

What will study participants be asked to do?

Half the people will receive the abatacept drug.

    • Half the people will get treated with a placebo that looks like abatacept but has no active drug (placebo).
    • You and the researcher will not know if you are taking abatacept or placebo.

Blood tests will be done to see the effects of abatacept and to learn how it may work in people who are at risk for developing diabetes. Abatacept treatment is given through a vein each month for one year.

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A randomized, double-blind, multiple dose, placebo-controlled study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and efficacy of secukinumab in adult and pediatric patients with new-onset type 1 diabetes mellitus (T1D) (Novartis)

The purpose of this research study is to test whether a new drug called secukinumab is safe in adults and children with newly diagnosed T1D and whether it can protect the remaining insulin-producing beta cells of the pancreas. This drug should be given as soon as someone is discovered to have T1D and no longer than 100 days from diagnosis to have the best chance to protect the remaining beta cells.

Who can participate?

    • Age 8-up to but not including 36 years old
    • Body weight of at least 21 but less than 121kg
    • First dose of the study medicine must be given within 100 days of the diagnosis of diabetes
    • Willing to avoid vaccinations with 'live vaccines' for 18 months (from 3 months prior to first dose until 3 months after last dose is given)

What will study participants be asked to do?

    • Half the people will get secukinumab.
    • Half the people will get something that looks like secukinumab but has no active compound (placebo).
    • You and the researcher will not know if you are taking secukinumab or placebo.

You will be asked to come to the doctor's office/clinic/study site about 25 times over 3 years. Up to 19 visits will occur in the first year when you will be given the study drug. How long each visit will last depends on what needs to be done at each visit. Most will take about 1-2 hours but some will take up to 3-4 hours.

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Additional Studies Offered at the University of Florida Diabetes Center

For studies being offered at the UF Diabetes Center, visit: http://diabetes.ufl.edu/research/

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Type 2 Diabetes (T2D) Research Studies

Colesevelam Oral Suspension as Monotherapy or Add‑on to Metformin Therapy in Pediatric Subjects with Type 2 Diabetes Mellitus (Wel-A-U307; WelKid)

Does your child have Type 2 Diabetes?

We are currently doing a clinical research study in children to look at the safety and effectiveness of a medicimne approved by the FDA for treatment of Type 2 Diabetes in adults.

Who can participate?

    • Children who are 10-17 years of age with Type 2 Diabetes may qualify to be in this clinical research study.

Qualified participants will receive:

    • Study-related medication
    • Study-related lab tests
    • Study-related blood sugar testing
    • Study-related physical exams

What will study participants be asked to do?

Those joining the study will mix the medicine with water or other liquid and drink it once a day. There will be about 9 study visits in the clinic with phone calls in between. During these visits, blood will be taken and other information will be collected. Participants will be provided with the study medicine and related supplies, as well as a glucose meter and some test strips.

THIS STUDY IS ACTIVELY RECRUITING!

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Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with Type 2 Diabetes (ELLIPSE, NN2211-3659)

We are currently doing a clinical research study in children to look at the safety and effectiveness of a medicine approved by the FDA for treatment of Type 2 Diabetes in adults.

This 52-week study is evaluating the medication liraglutide.

The purpose of this study is to compare the blood sugar lowering effect and the safety of liraglutide (trial drug) and liraglutide placebo (no active drug) when it is given together with metformin treatment in children and adolescents (10-16 years) with Type 2 Diabetes. This will tell us if liraglutide is effective and safe to use in children and adolescents.

Who can participate?

    • Children who are 10-17 years of age
    • Diagnosed with Type 2 Diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy.

What will study participants be asked to do?

    • Half the people will get liraglutide and metformin.
    • Half the people will get liraglutide placebo (no active drug) and metformin.
    • You and the researcher will not know which group you are in.

Metformin is an oral anti-diabetes drug already approved for use in children and adolescents. All children in the trial will get metformin to make sure that all children receive treatment for their Type 2 Diabetes.

You will have 17 visits to the clinic and have at least 9 telephone calls over 52 weeks. During these visits, blood will be taken and other information will be collected. Participants will be provided with the study medication and related supplies, as well as a glucose meter and some test strips.

THIS STUDY IS ACTIVELY RECRUITING!

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A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-Release Metformin) in Pediatric Subjects with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (Merck 289)

The purpose of this study is to:

    • Test the safety and tolerability of the research study drug, sitagliptin (given as MK-0431A XR, also known as JanumetÔ XR), when added to extended-release metformin (metformin XR), in children 10-17 years old.
    • Assess the effect of treatment with sitagliptin and metformin XR, compared to placebo and metformin XR, on hemoglobin A1C in children 10-17 years old, after 20 weeks of treatment.

Who can participate?

    • Children 10-17 years of age
    • Diagnosed with Type 2 Diabetes
    • On a stable dose of metformin IR or XR (for at least 12 weeks or more)

What will study participants be asked to do?

Participants will be asked to take 4 study drug tablets one time per day by mouth before each morning meal.
Children participating in the study will have 9 clinic visits and several telephone calls over 56 weeks. During these visits, blood will be taken and other information will be collected. Participants will be provided with the study medicine and related supplies, as well as two glucose meters and some test strips.

THIS STUDY IS ACTIVELY RECRUITING!

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) As Monotherapy In Pediatric Patients With Type 2 Diabetes (BMS CV181-058)

Does your child have Type 2 Diabetes? If so, your child may be eligible to participate in a clinical study of a study medicine that is already approved for adults.

This clinical research study will test the effectiveness and safety of saxagliptin, a study drug being developed to see if it can treat T2DM for children age 10 to 18 years old.*
*Your child's age must be no more than 17 years and 32 weeks at the time that he/she receives the first dose of study medicine.

Who can participate?

    • A child that is at least 10, but less than 18 years of age.
    • Must have been diagnosed with Type 2 Diabetes within the past 2 years.
    • Must not be taking insulin or other diabetes medicines.

Qualified participants with receive:

    • Research medication or placebo
    • Medical care
    • Lab work and evaluations
    • Glucose-testing supplies
    • Diabetes and exercise counseling

What will study participants be asked to do?
Participants will be asked to take study drug tablet one time per day by mouth.

    • Half the people will get saxagliptin (2.5 mg or 5.0 mg)
    • Half the people will get saxagliptin placebo (no active drug)
    • You will not know which group you are in.

You will have 15 visits to the clinic and have some telephone calls over 55 weeks. During these visits, blood will be taken and other information will be collected. Participants will be provided with the study medicine and related supplies, as well as a glucose meter and some test strips.

THIS STUDY IS ACTIVELY RECRUITING!

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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone (BMS CV181-147)

Does your child have Type 2 Diabetes? If so, your child may be eligible to participate in a clinical study of an study medicine.

This clinical research study will test the effectiveness and safety of saxagliptin, an study drug being developed to see if it can treat T2DM for children age 10 to 18 years old.*
* Your child's age must be no more than 17 years and 30 weeks at the time of screening.

Who can participate?

    • A child that is at least 10, but less than 18 years of age.
    • Must have been diagnosed with Type 2 Diabetes at least 2 months ago.
    • Be on a stable Glucophage® (metformin) treatment
    • Have poor blood sugar control on Glucophage® (metformin) alone

Qualified participants with receive:

    • Research medication or placebo
    • Medical care
    • Lab work and evaluations
    • Glucose-testing supplies
    • Diabetes and exercise counseling

What will study participants be asked to do?

    • Half the people will get saxagliptin (2.5 mg or 5.0 mg)
    • Half the people will get saxagliptin placebo (no active drug)
    • You will not know which group you are in.

You will have 15 visits to the clinic and have some telephone calls over 57 weeks. During these visits, blood will be taken and other information will be collected. Participants will be provided with the study medicine and related supplies, as well as a glucose meter and some test strips.

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Growth Hormone Research Studies

A Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children with Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy after Subcutaneous Administration for 6 months. (VERTICAL, 12VR2)

The standard treatment for growth hormone deficiency is daily injections of human growth hormone. The purpose of this study is to see how well a longer-acting growth hormone will work in children. The new growth hormone is called VRS-317. VRS-317 is made of natural human growth hormone but it has been modified to make its effects last longer. This is the first time VRS-317 will be given to children.

Who can participate?

    • Girls aged 3 to 10 years old
    • Boys ages 3 to 11 years old
    • Diagnosis of Growth Hormone Deficiency

What will study participants be asked to do?

Each participant will receive up to 4 VRS-317 injections under the skin each month for six months. There will be approximately 7 visits to the doctor's office that may be done by a nurse at your home. During these visits, blood will be drawn and other information will be collected.

THIS STUDY IS ACTIVELY RECRUITING!

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The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

The purpose of this research study, the Genetics and Neuroendocrinology of Short Stature International Study (known as GeNeSIS), is to better understand childhood growth, growth problems, and their treatment by collecting information regarding the diagnosis and treatment of your child's condition.

Who can participate?

    • Treatment with Humatrope brand of growth hormone for improvement of growth.
    • No treatment with human growth hormone in patients with history of cancer or in those with any SHOX-related genetic disorder.

What will study participants be asked to do?

Your child's doctor will collect information regarding your child's medical history, physical examination, growth and routine laboratory studies.

THIS STUDY IS ACTIVELY RECRUITING!

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