Research Studies

Diabetes Center Research Studies

Find research studies available to children cared for by the Diabetes Center team.
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Clinical trial
Children (4)
Adults (2)

Clinical Trial Phases
Phase I (1)
Phase II (1)
Phase IV (1)
N/A (1)

Recruitment Status
Recruiting (3)
Non-recruiting (1)

Related Specialties and Programs
Diabetes Center (4)
Division of Endocrinology and Diabetes (2)

Specialty
Diabetes Care (4)
Endocrinology (2)

Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection
The aim of this study is to evaluate safety, and tolerability of insulin LY3209590 following a single dose given to children with type 2 diabetes mellitus (T2DM). This will be the first study to evaluate LY3209590 in pediatric patients with T2DM. 
ScreeningAll participants will be screened up to 28 days prior to dosing.
Treatment and Assessment Period On Day 1, participants will receive a single 100-Unit subcutaneous dose of LY3209590 at the clinical research unit. Follow up research visits will be performed on Days 3, 5, 7, 15, 29, 43, and 65. Blood sampling and safety assessments will be performed at each in clinic visit. Before each study visit, subjects will need to fast for at least 8 hours.
A follow-up telephone call will be performed on approximately Day 72. The total time for participation is the study is about 100 days. 

Phase: Phase I

Actively recruiting: Yes

Category: Children

CODA: COVID-19 and Diabetes Assessment

The goals of this research study are to find out how having COVID-19 recently affects blood sugar, inflammation, and insulin in people with type 1 and type 2 diabetes. We also want to see if COVID-19 changes blood vessel health or makes blood clot more easily. We will also look at how things like genes, lifestyle, and environment might affect these issues.

Phase: N/A

Actively recruiting: Yes

Category: Adults, Children

FrexalimAB in preservation of endogenous insULIN secretion compared to placebo in adUlts and adolescents on top of inSulin therapy (FABULINUS)
The goal of this Phase 2 study is to assess safety and efficacy of frexalimab to preserve β-cell function in participants with newly diagnosed type 1 diabetes (T1D). In Part A, an exploratory part, adults (ages 18-35) will be treated with either high dose frexalimab, or placebo (inactive study drug). In Part B, adolescents and young adults (ages 12-21) will be treated with 3 dose levels of frexalimab or placebo.

Phase: Phase II

Actively recruiting: Yes

Category: Adults, Children

PETITE-T1D
The purpose of this study is to evaluate the safety and pharmacokinetics (drug levels in the blood) of teplizumab in children less than 8 years old. The study will also assess if your child stays in Stage 2 T1D or progresses to Stage 3 T1D. Your child may join the study only if they are in Stage 2 T1D.
Previous studies in adults and children older than 8 years of age suggest that taking teplizumab, a drug that affects your child’s immune system, may stop, delay, or decrease the attack on the cells that make insulin. This slowing or blocking of the immune attack may reduce the risk of short-term and long-term consequences of T1D.
To join this study, your child must have been diagnosed with Stage 2 T1D based on two positive T1D-related antibodies and confirmed dysglycemia (abnormal blood sugar levels) based on an oral glucose tolerance test, fasting plasma glucose test, or an increase in a blood test called the hemoglobin A1c. 
The study is “open-label.” That means that if your child qualifies for the study, your child will receive teplizumab. There is no placebo in this study.

Phase: Phase IV

Actively recruiting: No

Category: Children