Type 2 Diabetes Research Study
Learn about our current research studies related to type 2 diabetes and how you can participate.
Current Research
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Single Dose Alogliptin (Takeda Study)
(Ages 10-17)
| Study name: | A comparative, randomized, open-label, multi-center, single dose pharmacokinetic, pharmacodynamic and safety study of Alogliptin (12.5 mg and 25mg) between children, adolescents, and adults with type 2 (non-insulin dependent) diabetes mellitus |
| Study sponsors: | Takeda Global Research and Development Center, Inc. |
| Principal investigator: | Steven Willi, MD, Director of the Diabetes Center at CHOP |
Who can participate?
- Children and adolescents between 10 and 17 years old
- Diagnosed with Type 2 Diabetes
- Do not require insulin injections
- In good general health
What is this study about?
The purpose of this research study is to see how much of the new medication, alogliptin, gets into the bloodstream after taking a tablet by mouth and how safe it is.
What does participation involve?
The study consists of a Screening visit, a Treatment period (3 days inpatient stay and 2 clinic visits), and a 14-day follow-up phone call.
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
- ECG
Eligible volunteers who consent to participate will be randomly assigned to one of two groups to receive one dose of either 12.5mg or 25mg of alogliptin orally while on the inpatient floor. After being discharged from the hospital, subjects will return to the clinic for a blood sample collection and other study procedures for 2 more days (one hour duration each).
How long will this study last?
Total clinical trial participation may last from 18 to 44 days, depending on when the treatment begins after the screening visit.
Reimbursement
Study-related care and supplies are provided at no cost to you. Participants will be compensated for travel and related expenses. In addition, volunteers will be compensated for the completed study visits.
More information
For more information about this study, please visit ClincalTrials.gov.
Contact us
If interested, please email diabetesresearch@email.chop.edu or call: 267-426-7519.
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Colesevelam Oral Suspension
(Ages 10-17)
| Study name: | Colesevelam Oral Suspension as Monotherapy or Add-on to Metfromin Therapy in Pediatric Subjects with Type 2 Diabetes Mellitus |
| Study sponsors: | Daiichi Sankyo Pharma Development |
| Principal investigator: | Lorraine Levitt Katz, MD |
Who can participate?
- Children and adolescents between 10 and 17 years old
- Diagnosed with type 2 diabetes
- Do not require insulin injections
- In good general health
What is this study about?
The purpose of this research study is to see if colesevelam (Welchol®) is an effective treatment to lower Hemoglobin A1c (HbA1c) levels, a measure of blood sugar, in children and adolescents with type 2 diabetes.
What does participation involve?
The study consists of a screening visit, a two-week Lead-in period while first on colesevelam, then a 12-month Treatment period, and a final follow-up visit after 2 weeks.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 and assent to participate, as appropriate, will be randomly assigned to receive either high-dose colesevelam or low-dose taken once daily as a powder mixed in a liquid such as water.
What is important to consider about this study?
- Neither you nor the study physician and team will know which dose of colesevelam you have been assigned.
- There is no guarantee that colesevelam will work. In the event your HbA1c is high while on colesevelam treatment, other Type 2 Diabetes-medications (Metformin and insulin) may be prescribed.
- All volunteers will receive intensive diabetes management from expert medical staff while participating in the study.
How long will this study last?
Total clinical trial participation lasts about 58 weeks – depending on when the treatment begins after the screening visit.
Reimbursement
Study-related care and supplies are provided at no cost to you. Participants will be compensated for travel and related expenses. In addition, volunteers will be compensated for the completed study visits.
More information
For more information about this study, please visit ClincalTrials.gov.
If interested
Please email diabetesresearch@email.chop.edu or call: 267-426-7519
CHOP #: 10-007883
Approval Date: 12/16/11
Expiration Date: N/A
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TODAY Genetics
| Study name: | Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study Group Genetics |
| Study sponsors: | National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) |
| Principal investigator: | Lorraine Levitt Katz, MD |
Who can participate?
- Those diagnosed with type 2 diabetes before 18 years of age
- Have proof of Body Mass Index (BMI) above the 85th percentile at diagnosis
- Do not have a genetic syndrome known to affect glucose tolerance other than diabetes
What is this study about?
The purpose of this research study is to collect blood and medical information to explore the relationships between candidate genes and type 2 diabetes mellitus, as well as obesity and insulin resistance. This work may lead to the development of new diagnostic tests and treatments for diabetes and other related diseases.
What does participation involve?
If you decide that you want to determine if you qualify for this study, please contact the study staff through the e-mail address or phone number listed below.
Eligible volunteers that give permission to participate through appropriate consent and assent forms will be asked to complete a single screening visit in which you can expect:
- Interviews about your and your family’s medical history
- A single blood collection for testing
The blood samples and information will be collected and tracked through a coded number to protect the privacy of all volunteers.
Reimbursement
Participants will be compensated for their time and effort required to complete the study visit. Additionally, volunteers can be compensated for travel expenses if applicable.
More information
For more information about this study, please visit ClincalTrials.gov.
If interested
Please email gralewskik@email.chop.edu or call: 267-426-7433
CHOP #: 08-006165
Approval Date: 12/20/11
Expiration Date: N/A
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Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2)
| Study name: | Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) Study-Immediate Post Intervention Phase 1 (Enrollment open to TODAY participants only) |
| Study sponsors: | National Institute of Health (NIH) and National Institute of Digestive and Kidney Disease (NIDDK) |
| Principal investigator: | Lorraine Levitt Katz, MD |
What is the TODAY2 Study?
The TODAY2 Study (phase 1) is funded by the National Institutes of Health. It is a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. T2P1 offers standard diabetes care , treatment and management with monitoring and follow-up. During this period, the findings of TODAY are being analyzed and interpreted by the study group.
The primary goal of this first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:
- Understand the persistence of the effects of the different treatment regimens used in TODAY,
- Describe the continued evolution of beta cell function, and
- Describe the development of vascular complications and risk factors for complications.
Who is involved?
Anyone randomized into the TODAY study is eligible to participate in TODAY2. Enrollment is currently open.
What is the value of the TODAY and TODAY2 Studies to youth with type 2 diabetes?
The TODAY2 study is the first study of its kind to evaluate a cross section of youth with type 2 diabetes and follow them for a length of time.
More information
For more information please contact: schwartzmann@email.chop.edu or call 267.426.5718
CHOP IRB# 7869
Approval Date: 10/31/11
Expires: 10/30/12
Other Projects (Past and Ongoing)
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Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (Enrollment Closed)
| Study name: | Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study (Enrollment Closed) |
| Study sponsors: | National Institute of Health (NIH) and National Institute of Digestive and Kidney Disease (NIDDK) |
| Principal investigator: | Lorraine Levitt Katz, MD |
What is the TODAY Study?
The TODAY Study was funded by the National Institutes of Health. It examined the safety and efficacy of three treatment arms for type 2 diabetes in the pediatric population. The study was initiated due to the increase in type 2 diabetes in children and adolescents, related to the rise in obesity and sedentary behaviors in American youth.
Who is involved?
TODAY enrolled over 700 children, age 10-17, at 15 sites around the United States, and followed them for two to seven years. Enrollment began in May 2004 and was completed in February 2009.
What is the value of the TODAY Study to youth with type 2 diabetes?
The TODAY study was the first study of its kind to evaluate a cross section of youth with type 2 diabetes and follow them for a length of time. The study evaluated the best methods to treat youth with type 2 diabetes including metformin, metformin plus rosiglitazone and metformin plus lifestyle intervention.
More information
For more information please contact: schwartzmann@email.chop.edu or call 267.426.5718.
CHOP IRB# 3590
Approval Date: 8/23/11
Expires: 8/22/12
Contact Us
Find out about current clinical trials at CHOP:
Type 1 Diabetes
Type 2 Diabetes
If you are interested in participating in our studies and research please contact us:
- 267-426-7519
- Contact Us Online