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Type 2 Diabetes MellitusMetaHcQNCT02026232

Metabolic Effects of Hydroxychloroquine

A study testing Hydroxychloroquine in people with Type 2 Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes to hydroxychloroquine, 200 mg twice daily or placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Hydroxychloroquine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited States
Study dates
Mar 2012to 15 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects between the age of 18 and 75, either gender, any ethnic group
  • Subjects must have type 2 diabetes and the following:
  • A1c of 6.5-9.0%
  • Treated with at least 1000 mg of metformin daily with or without a dipeptidyl peptidase-4(DPP4)inhibitor, a sulfonylurea (glipizide, glyburide, glimepiride),bromocriptine or colesevelam.
  • Subjects should have a BMI >27

Who cannot join

  • Prior treatment with chloroquine or hydroxychloroquine as follows:
  • any exposure in the past 2 years,
  • >30 days of therapy if exposure was between 2 and 5 years ago,
  • >90 days of therapy if exposure was between 5 and 10 years ago,
  • >6 months of therapy if exposure was 10 to 20 years ago,
  • >1 year of therapy if exposure was 20 to 30 years ago,
Show all 28Show fewer
  • No limit if last exposure was >30 years ago, e.g. during the Vietnam conflict.
  • Morbid obesity (BMI >45)
  • Coronary artery disease or other vascular disease
  • History of stroke
  • Serum creatinine >-4 mg/dl for women and >-5 mg/dl for men.
  • Seizure disorder
  • History of psoriasis
  • Hematologic disorders, including anemia (WHO criteria for anemia:hemoglobin <13g/dL in men and <12 g/dL in women)
  • Current malignancy or active treatment for recurrence prevention,e.g. tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
  • Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if continuous positive airway pressure(CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
  • Treatment with 50mg or greater of Metoprolol or treatment with digoxin
  • Liver disease, or Liver Function Test >2 times normal
  • Active infection (including HIV)
  • Serious illness requiring ongoing medical care or medication
  • Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
  • Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm/day of fish oils
  • Uncontrolled hypertension (BP >150/90 mm Hg) at enrollment
  • Need for daily Over The Counter medications, or currently taking cimetidine or >1000 IU vitamin E daily and unwilling to reduce or discontinue vitamin E or discontinue cimetidine for the duration of the study. Patients taking more than 1000 IU vitamin E daily should reduce or discontinue the vitamin for 30 days before randomization.
  • Pregnant or lactating women, or women intending to become pregnant
  • Women not using adequate birth control (hormonal birth control is acceptable, also double barrier)
  • QT corrected >450 msec on screening ECG
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes to hydroxychloroquine, 200 mg twice daily or placebo.

Read the detailed description

Hydroxychloroquine is a medicine that has been used for a long time to treat patients with malaria, rheumatoid arthritis, lupus and other conditions. It is closely related to chloroquine but with a better side effect profile for long term use. In treating these conditions it was discovered to have some beneficial properties like lowering cholesterol and lowering sugar in the blood of those who have diabetes. The mechanisms underlying these effects are unknown. In animal studies, we have discovered that chloroquine appears to decrease glucose, lower blood pressure and decrease atherosclerosis (hardening of the arteries). This collection of problems commonly occurs in the metabolic syndrome and diabetes mellitus, which affects over 20% and 7% of adults in Western countries respectively. We have recently looked at the effects of chloroquine on the metabolic syndrome in humans which showed that small doses given for a short period of time would reduce insulin resistance in patients with the metabolic syndrome. Several population studies have shown similar effects with hydroxychloroquine. Since hydroxychloroquine is similar to chloroquine, we thus expect similar effects on blood glucose, blood pressure and blood cholesterol in type 2 diabetes. This offers a unique opportunity to develop a novel approach for lowering blood pressure, lipids (cholesterol and triglycerides), and glucose in people at risk for heart disease

Being tested
Hydroxychloroquine, Hydroxychloroquine Placebo
Keywords
Type 2 Diabetes, Overweight
Medical subject headings
Diabetes Mellitus, Type 2, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxychloroquineDrug

    Also called Plaquenil, Quineprox

    200mg twice daily

  • Hydroxychloroquine PlaceboOther

    Also called placebo

    200mg placebo twice daily

Study groups in NCT02026232
Study groupRoleWhat they receive
hydroxychloroquineActive comparatorhydroxychloroquine twice daily for 4 weeks
Receives: Drug: Hydroxychloroquine
PlaceboPlacebo comparatorhydroxychloroquine placebo twice daily for 4 weeks
Receives: Other: Hydroxychloroquine Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of HCQ on Fasting Blood Glucose

    determined by fasting blood glucose performed at baseline and follow-up

    Measured: 4 weeks

Secondary outcomes (1)

  1. Effect of HCQ on Fasting Low Density Lipoprotein

    determined by lipid profile with calculated LDL performed at baseline and follow-up

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study startMar 2012
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Why it stopped: COVID-19 \& loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026232
Sponsor's protocol ID
201110258
Other IDs
201110258
Acronym
MetaHcQ
Status last verified
Dec 2023
First submitted
24 Dec 2013
Last updated
28 Dec 2023
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.

    PubMed 21366474

  • Schramm TK, Gislason GH, Kober L, Rasmussen S, Rasmussen JN, Abildstrom SZ, Hansen ML, Folke F, Buch P, Madsen M, Vaag A, Torp-Pedersen C. Diabetes patients requiring glucose-lowering therapy and nondiabetics with a prior myocardial infarction carry the same cardiovascular risk: a population study of 3.3 million people. Circulation. 2008 Apr 15;117(15):1945-54. doi: 10.1161/CIRCULATIONAHA.107.720847. Epub 2008 Mar 31.

    PubMed 18378618

  • Schneider JG, Finck BN, Ren J, Standley KN, Takagi M, Maclean KH, Bernal-Mizrachi C, Muslin AJ, Kastan MB, Semenkovich CF. ATM-dependent suppression of stress signaling reduces vascular disease in metabolic syndrome. Cell Metab. 2006 Nov;4(5):377-89. doi: 10.1016/j.cmet.2006.10.002.

    PubMed 17084711

  • Marmor MF, Kellner U, Lai TY, Lyons JS, Mieler WF; American Academy of Ophthalmology. Revised recommendations on screening for chloroquine and hydroxychloroquine retinopathy. Ophthalmology. 2011 Feb;118(2):415-22. doi: 10.1016/j.ophtha.2010.11.017.

    PubMed 21292109

  • Su Y, Swift M. Mortality rates among carriers of ataxia-telangiectasia mutant alleles. Ann Intern Med. 2000 Nov 21;133(10):770-8. doi: 10.7326/0003-4819-133-10-200011210-00009.

    PubMed 11085839

  • Razani B, Feng C, Semenkovich CF. p53 is required for chloroquine-induced atheroprotection but not insulin sensitization. J Lipid Res. 2010 Jul;51(7):1738-46. doi: 10.1194/jlr.M003681. Epub 2010 Mar 5.

    PubMed 20208057

Questions about this trial

What is this clinical trial studying?

A study testing Hydroxychloroquine in people with Type 2 Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of HCQ on Fasting Blood Glucose (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02026232, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.

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Metabolic Effects of Hydroxychloroquine (NCT02026232) | AzTrials