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Antimalarial

Hydroxychloroquine for Type 1 Diabetes (TN-22 Trial)

Phase 2
Waitlist Available
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up glucose tolerance is measured every 6 months for up to 4 years
Awards & highlights

TN-22 Trial Summary

This trial will compare the effects of hydroxychloroquine, versus placebo, on the progression of T1D in people who have recently been diagnosed.

Eligible Conditions
  • Type 1 Diabetes

TN-22 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~glucose tolerance is measured every 6 months for up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and glucose tolerance is measured every 6 months for up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

TN-22 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HydroxychloroquineExperimental Treatment1 Intervention
Hydroxychloroquine compound for oral use
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet matching active drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,356 Previous Clinical Trials
4,314,793 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,476 Total Patients Enrolled
Carla Greenbaum, MDStudy ChairType 1 Diabetes TrialNet
10 Previous Clinical Trials
332 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Hydroxychloroquine as a viable treatment option?

"Hydroxychloroquine's safety was assigned a score of 2 since the trial is at Phase 2, indicating that there are some data which demonstrate its security but none which suggest efficacy."

Answered by AI

What medical conditions does Hydroxychloroquine commonly address?

"Hydroxychloroquine is typically used to tackle malaria, but can also be employed in the management of q fever, rheumatoid arthritis and sjögren's syndrome."

Answered by AI

How many centers are overseeing this experiment?

"This medical experiment is being conducted in 43 centres, including Children's Hospital Los Angeles of LA, California; Joslin Diabetes Center of Boston, Massachusetts and Cleveland Clinic Foundation in Ohio."

Answered by AI

How many participants is this clinical experiment recruiting?

"This experiment is not actively recruiting participants at this time. Initially posted on August 15th 2018, the trial has been amended for the last time as of July 19th 2022. For those seeking alternative clinical trials, there are currently 1,258 studies involving diabetes mellitus and 64 investigations concerning Hydroxychloroquine that require volunteers."

Answered by AI

Are there additional investigations being conducted on Hydroxychloroquine?

"The initial research into hydroxychloroquine was conducted by the University of Nebraska Medical Centre in 2007. Since then, 18,435 studies have concluded with 64 active trials taking place around the world - particularly in Los Angeles."

Answered by AI

Are there any vacancies left in the clinical trial for potential participants?

"This clinical trial has finished their recruitment efforts. Initially posted on August 15th 2018, the last update was made July 19th 2022. Fortunately, there are still a variety of options available for those suffering from diabetes mellitus; 1258 trials and 64 specific to Hydroxychloroquine are actively seeking participants."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
2018. "Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03428945.
~41 spots leftby Apr 2025
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