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Research

Atlanta Diabetes Associates Clinical Research

Our mission is to provide patients and sponsors with the highest quality of clinical research available today. We strive to deliver efficient and accurate research data and strictly adhere to protocol guidelines, while maintaining patient safety as our number one priority.

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Currently Enrolling

Type 1 Diabetes

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI 1)
Eligibility
Sex / Gender

All

Ages

18 years and older

Accepts Healthy Volunteers

No

About
Primary Objective:

To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.

Sponsor

Sanofi

Estimated Primary Completion Date

January 2019

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A Study of LY900014 in Participants With Type 1 Diabetes (PRONTO-T1D)
Eligibility
Sex / Gender

All

Ages

18 years and older

Accepts Healthy Volunteers

No

About
Brief Summary:

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

Sponsor

Eli Lilly and Company

Estimated Primary Completion Date

September 6, 2018

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A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)
Eligibility
Sex / Gender

All

Ages

6 Years to 21 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Sponsor

Janssen Research & Development, LLC

Estimated Primary Completion Date

February 25, 2019

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Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System at Home
Eligibility
Sex / Gender

All

Ages

7 Years to 75 Years

Accepts Healthy Volunteers

No

About
Brief Summary:

The purpose of this study is to demonstrate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

Sponsor

Medtronic Diabetes

Estimated Primary Completion Date

August 2021

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Type 1 - Pediatrics

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
Eligibility
Sex / Gender

All

Ages

4 Years to 17 Years

Accepts Healthy Volunteers

No

About
Primary Objective:

To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).

Sponsor

Mannkind Corporation

Estimated Primary Completion Date

July 2020

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Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus (EDITION JUNIOR)
Eligibility
Sex / Gender

All

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

No

About
Primary Objective:

To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c)

Sponsor

Sanofi

Estimated Primary Completion Date

June 20, 2018

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Research Participant Application

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Type 2 Diabetes

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI 1)
Eligibility
Sex / Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

About
Primary Objective:

To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.

Sponsor

Sanofi

Estimated Primary Completion Date

January 2019

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Research Participant Application

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Diabetic Complications

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)
Eligibility
Sex / Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

About
Purpose:

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Sponsor

Bayer

Estimated Primary Completion Date

September 29, 2019

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People Without Diabetes

Pathway to Prevention Study
Eligibility
Sex / Gender

All

Ages

1-45 years

Accepts Healthy Volunteers

Yes

Study Population

First and second/third degree relatives of individuals with type 1 diabetes.

About
Brief Summary:

The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator
  • National Center for Research Resources (NCRR)
  • Juvenile Diabetes Research Foundation
  • American Diabetes Association

 

Estimated Primary Completion Date

July 2019

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