Diabetes Mellitus Type 2 With HyperglycemiaPhase 2NCT02303405
Hydroxychloroquine Versus Pioglitazone in Combination Treatment for Type 2 Diabetes Mellitus
A Phase 2 study testing Hydroxychloroquine and Pioglitazone in people with Diabetes Mellitus Type 2 With Hyperglycemia, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2 With Hyperglycemia
- What is being tested?
- Hydroxychloroquine and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2017
- Phase
- Phase 2
- 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
- Male or female, age 18-75, inclusive
- Known type 2 diabetes (diagnosed according to 1997 ADA diagnostic criteria)
- At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea
- Hemoglobin A1c ≥ 7.5% and < 11.0%
- Body mass index (BMI) < 45 kg/m2
- Able to comply with all scheduled visits and requirements of the protocol
Who cannot join
- Any contraindications to the use of metformin or a sulfonylurea
- Extreme hyperglycemia (FPG ≥ 300 mg/dL), symptoms of polyuria or polydipsia, or Hemoglobin A1c ≥ 11.0%
- Current use of insulin; history or clinical suspicion of type 1 diabetes mellitus
- Symptomatic hypoglycemia occurring at an average frequency > once per day
- Highly erratic dietary schedules, extremely food insecure households, or homelessness that may adversely affect good glycemic control, as judged by the investigators
- Occupations that involve regular operation of motor vehicles or other heavy machinery that may pose a hazard in the event of unanticipated blurred vision
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- Known history of Class III or IV heart failure, cardiac arrhythmias, severe peripheral edema, advanced osteoporosis, documented bladder malignancies, or other intolerance to pioglitazone
- Known history of collagen vascular disorders, glucose-6-phosphate dehydrogenase deficiency, hematologic disorders, psoriasis, or any known intolerance to hydroxychloroquine
- Known history of pre-proliferative or proliferative retinopathy, or any clinically significant retinal abnormalities noted on the patient's most recent (i.e., within 1 year) ophthalmologic exam; subjects who have not received their routine annual ophthalmologic surveillance for diabetic retinopathy within the past year must have their annual surveillance performed before screening
- An estimated GFR (by the Modification of Diet in Renal Disease (MDRD) formula) < 45 mL/min, or a history of nephrotic syndrome (defined as a spot urine protein-creatinine ratio of > 3500 mg per g urine creatinine)
- Subjects with active hemoglobin abnormalities that render the Hemoglobin A1c measurement unreliable
- History of any clinically significant hepatic, cardiovascular, infectious, dermatologic, psychiatric, or other major systemic disease that, in the opinion of the investigator, may make the use of pioglitazone or hydroxychloroquine unsafe, or otherwise make the interpretation of the data difficult.
- Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception or do not agree to use a reliable form of contraception. Reliable forms of contraception include systemic contraceptives (oral, implant or injection), diaphragm with spermicide, cervical cap, IUD, or condoms with spermicide.
- Current pregnancy or lactation.
- Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study (e.g., glucocorticoids).
- Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Comparing the Effects of Hydroxychloroquine (HCQ) to Pioglitazone in Type 2 Diabetic Patients Failing Maximal Doses of Metformin Plus a Sulfonylurea
A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
Read the detailed description
A 4-month, randomized, prospective, open-label comparison trial of 4 months of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
- Being tested
- Hydroxychloroquine, Pioglitazone
- Keywords
- Glucose Control, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Anti-inflammatory and anti-malarial agent
PioglitazoneDrug
Also called Actos
Anti-hyperglycemic agent
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Treatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months Receives: Drug: Hydroxychloroquine |
| Pioglitazone | Active comparator | Treatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Glycemic control
Measured: 4 months
Secondary outcomes (10)
Fasting Plasma Glucose
Fasting glucose level
Measured: 4 months
Percent of Subjects Achieving HbA1c < 7.5%
Percent of subjects achieving a HbA1c level < 7.5%
Measured: 4 months
Weight
Body weight
Measured: 4 months
Body Mass Index
Body mass index (BMI)
Measured: 4 months
HOMA-IR
Insulin resistance by the HOMA model
Measured: 4 months
QUICKI
Insulin resistance by the QUICKI model
Measured: 4 months
Hs-CRP
Highly-sensitive C-reactive protein (inflammatory marker)
Measured: 4 months
Leucocyte Count
White cell count (surrogate marker of inflammation)
Measured: 4 months
Hypoglycemic Events
Number of hypoglycemic events
Measured: 4 months
Adverse Events
All other adverse events other than hypoglycemia
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus Type 2 With HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley H Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303405
- Sponsor's protocol ID
- 14-01-2419
- Status last verified
- Sep 2022
- First submitted
- 25 Nov 2014
- Last updated
- 20 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Hydroxychloroquine (HCQ) to Pioglitazone in Type 2 Diabetic Patients Failing Maximal Doses of Metformin Plus a Sulfonylurea
- ClinicalTrials.gov ID
- NCT02303405
- Acronym / sponsor ID
- 14-01-2419
- Keywords
- Glucose Control, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Posted 20 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 4-month, randomized, prospective, open-label comparison trial of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
Detailed description
A 4-month, randomized, prospective, open-label comparison trial of 4 months of hydroxychloroquine vs. pioglitazone in type 2 diabetic patients inadequately controlled on maximally tolerated doses of metformin plus a sulfonylurea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineTreatment with hydroxychloroquine 400 mg (2 x 200 mg tablets) po once daily x 4 months |
| Pioglitazone | Active comparator | Drug: PioglitazoneTreatment with pioglitazone 45 mg po (1 tablet) once daily x 4 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age 18-75, inclusive
- Known type 2 diabetes (diagnosed according to 1997 ADA diagnostic criteria)
- At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea
- Hemoglobin A1c ≥ 7.5% and < 11.0%
- Body mass index (BMI) < 45 kg/m2
Key exclusion criteria (17 listed)
- Any contraindications to the use of metformin or a sulfonylurea
- Extreme hyperglycemia (FPG ≥ 300 mg/dL), symptoms of polyuria or polydipsia, or Hemoglobin A1c ≥ 11.0%
- Current use of insulin; history or clinical suspicion of type 1 diabetes mellitus
- Symptomatic hypoglycemia occurring at an average frequency > once per day
- Highly erratic dietary schedules, extremely food insecure households, or homelessness that may adversely affect good glycemic control, as judged by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilAnti-inflammatory and anti-malarial agent | Drug | Hydroxychloroquine |
| PioglitazoneAlso: ActosAnti-hyperglycemic agent | Drug | Pioglitazone |
Primary outcome
Hemoglobin A1c
Time frame: 4 months
Glycemic control
10 secondary outcomes
Fasting Plasma Glucose
Time frame: 4 months
Percent of Subjects Achieving HbA1c < 7.5%
Time frame: 4 months
Weight
Time frame: 4 months
Body Mass Index
Time frame: 4 months
HOMA-IR
Time frame: 4 months
QUICKI
Time frame: 4 months
Hs-CRP
Time frame: 4 months
Leucocyte Count
Time frame: 4 months
Hypoglycemic Events
Time frame: 4 months
Adverse Events
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley H Hsia, MD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine and Pioglitazone in people with Diabetes Mellitus Type 2 With Hyperglycemia, run by Charles Drew University of Medicine and Science 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 6 inclusion and 17 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 20 Oct 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2022). 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?
Hemoglobin A1c (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.