Type 1 Diabetes Research Study

Who can participate?

New onset type 1 diabetes, within 100 days of diagnosis

• 12 to 35 years of age
• Show positive results for at least one diabetes-related antibody
• Still making a minimum amount of insulin
• In good general health

What is this study about?

The purpose of this research study is to see if alefacept will slow or halt the progression of Type 1 Diabetes Mellitus in newly diagnosed individuals and to learn more about its safety. Alefacept is a drug that subdues the immune system. It is currently approved by the FDA to treat adults for an autoimmune skin disorder called psoriasis.

What does participation involve?

If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:

• Interviews about you medical history
• Physical examination
• Blood and urine samples collection for testing

Eligible volunteers who consent to participate will be randomly assigned to one of two groups. One group will be given the study drug, alefacept, and the other group will receive an inactive substance made to look like the study drug, called a placebo. Neither you nor the study physicians or nurses will know to which group you have been assigned. There is no guarantee that alefacept will work, or that you will receive the active drug (rather than the placebo).

Participants will receive a total of 24 weekly intramuscular injections of either alefacept or placebo:

• Cycle 1 (12 weeks) – clinic visit once a week + alefacept / placebo
• Pause (12 weeks) – clinic visit once a month
• Cycle 2 (12 weeks) – clinic visit once a week + alefacept / placebo
• Follow-up (15 months) – clinic visits once every 6 months

Regardless of whether you receive the experimental treatment or placebo, all participants will receive intensive diabetes management from expert medical staff, with the goal to keep blood glucose as close to normal as possible, thus enhancing your overall care.

How long will this study last?

Total clinical trial participation will last about 2 years.

Is there any payment?

Participants will be compensated for their time and reimbursed for travel and related expenses. Study-related care and study-related diabetes supplies will be provided at no cost to you.

More information

For more information please visit ClinicalTrials.gov and Immune Tolerance Network.

If interested please email diabetesresearch@email.chop.edu or call: 267-426-7519.

CHOP IRB#: 11-008125
Approval Date: 5/27/2011
Expiration Date: N/A

Who can participate?

• New onset type 1 diabetics, within 100 days of diagnosis
• 8 to 35 years of age
• Show positive results for at least one diabetes-related autoantibody
• Still making a minimum amount of insulin
• In good general health

What is this study about?

The purpose of this research study is to see if Alpha-1 Antitrypsin (AAT) will slow or halt the progression of type 1diabetes Mellitus in newly diagnosed individuals and to learn more about its safety. Aralast/AAT is an anti-inflammatory drug that affects immune cells that are thought to be involved in the development of type 1 diabetes. Aralast and drugs like it have been safely used for over 20 years to treat some types of emphysema.

What does participation involve?

If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:

• Interviews about your medical history
• Physical examination
• Blood and urine samples collection for testing

Eligible volunteers that consent to participate will be randomly assigned to one of two groups. One group will be given the study drug, Alpha-1 Antitrypsin, and the other group will receive an inactive substance made to look like the study drug, called a placebo. Neither you or the study physicians and nurses will know to which group you have been assigned. There is no guarantee that Alpha-1 Antitrypsin will work, or that you will receive the active drug (rather than the placebo).

A few things you should know about participating in the RETAIN study

• Participants will receive intravenous infusions of either the study drug or an inactive placebo a total of 12 times
• Participation is voluntary and you may quit the study at any time, for any reason
• Regardless of whether you receive the experimental treatment or placebo, all participants will receive intensive diabetes management from expert medical staff, with the goal to keep blood glucose as close to normal as possible, thus enhancing your overall care

How long will this study last?

Participation will last up to two years (12 infusion visits and about 8 follow-up visits).

Reimbursement

Participants will be compensated for travel and related expenses. All study-related care and study drug are provided at no cost to you.

More information

• Clinical Trials.gov - A Research Trial of Aralast in New Onset Diabetes
• Retain - A research trial of Aralast in new-onset type 1 diabetes

If you are interested in the study

Please email diabetesresearch@email.chop.edu or call 267-426-7519.

CHOP IRB#: 10-007788
Approval Date: 9/15/2011
Expiration Date: N/A

Who can participate?

• Children and adolescents between 1 and 17 years old
• Diagnosed with Type 1 Diabetes
• Using insulin daily for at least three months
• Hemoglobin A1C ≤ 11%
• In good general health

What is this study about?

The purpose of this research study is to compare the blood sugar lowering effect and safety of a new ultra-long acting insulin product (degludec) with that of a marketed long acting insulin product (detemir) used to treat type 1 diabetes in children and adolescents.

What does participation involve?

If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:

• Interviews about your medical history
• Physical examination
• Blood and urine samples collection for testing

Eligible volunteers that consent to participate will be randomly assigned to one of two groups. One group will be given the investigational study drug, degludec insulin, and the other group will receive detemir insulin. Both groups will receive the same fasting acting insulin (aspart).

CHOP is a participating CGM (continuous glucose monitoring) site. CGM provides a way to measure glucose measurements every 5 minutes. CGM is done two times during the study. Subjects will decide if they want to participate in the CGM portion of the study

A few things you should know about participating in the Degludec study

• Participation is voluntary and you may quit the study at any time, for any reason
• Regardless of whether or not you receive the investigational product (Degludec insulin), all participants will receive intensive diabetes management from expert medical staff, with the goal to keep blood glucose as close to normal as possible, thus enhancing your overall care

How long will this study last?

Participation will last 6 months

Reimbursement

Participants will be compensated for travel and related expenses. All study-related care and study drug are provided at no cost to you.

More information

For more information please visit ClinicalTrials.gov.

If interested in the study, please email diabetesresearch@email.chop.edu or call 267-426-7519.

CHOP IRB#: 11‐008552
Approval Date: 03/08/2012 
Expiration Date: N/A

Who can participate?

•  Those 1-45 years old with an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
• Those 1-20 years old with an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)  

What is this study about?

The purpose of this research study is to learn more about the development of type 1 diabetes in order to better characterized the risk of diabetes and identify factors that may be important to the pathway for prevention and improved treatments.

What does participation involve?

 The study consists of an initial screening visit for all eligible volunteers. A blood sample will be collected and screened for diabetes-related autoantibodies. These autoantibodies can lead to type 1 diabetes in some people, though not all. We only expect about 5% (or 1 in 20) eligible volunteers to screen positive.

What is important to consider about screening?

• Screening positive for the autoantibodies does not mean you will get type 1diabetes. It means you are at an increased risk.
• Also, screening negative does not mean you will never get diabetes, but your risk is much lower than if you were positive. That might change. So, volunteers under 18 years old can be screened every year.
• Volunteers that screen positive may be eligible for additional testing to learn more about their risk of type 1. This testing would be completed at visits up to twice a year.
• Volunteers that screen positive may also be eligible for other TrialNet studies that attempt to delay or prevent the onset of Type 1 Diabetes (See TrialNet Oral Insulin).

How long will this study last?

Total clinical trial participation may last from a one-time blood draw up to follow-up visits every 6 months.

Reimbursement

Study-related care and supplies are provided at no cost to you. Participants that screen positive and complete the additionally testing will be compensated for their time and effort required for the study visits.

More information

• Type 1 Diabetes TrialNet website
• ClinicalTrials.gov - Natural History Study of the Development of Type 1 Diabetes

If you are interested in the study

Please email gralewskik@email.chop.edu or call: 267-426-7433

CHOP #: 04-003946
Approval Date: 12/16/11
Expiration Date: N/A