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Cardiovascular DiseasePhase 3NCT01444651

A Trial of Tadalafil and Glycemic Traits

A Phase 3 study testing Tadalafil in people with Cardiovascular Disease and Insulin Resistance, run by Thomas J. Wang, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Tadalafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
1 siteUnited States
Study dates
Aug 2011to Mar 2013
Phase
Phase 3
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age > 18 years and < 50 years
  • BMI > 30 kg/m2
  • Fasting insulin > 10 uU/mL

Who cannot join

  • Systolic blood pressure (SBP) < 100, > 150 mmHg
  • Current anti-hypertensive medication use, including diuretics
  • Current use of organic nitrates
  • Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
  • History of reaction to PDE-5 inhibitors
  • Known HIV infection
Show all 17Show fewer
  • Use of medications that strongly alter CYP3A4 activity
  • History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
  • Known non-arteritic ischemic optic retinopathy (NAIOR)
  • History of hearing loss
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
  • Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
  • Known pregnancy or those unwilling to avoid pregnancy during the course of the study
  • History of priapism
  • Use in excess of four alcoholic drinks daily
  • History of diabetes mellitus or use of anti-diabetic medications
  • Known anemia (men, Hct < 38% and women, Hct < 36%)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts

Other trials in United States

About this study

Official title: Phase 3 Randomized Trial of Tadalafil and Glycemic Traits

The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

Read the detailed description

This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.

The investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.

The investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.

Being tested
Tadalafil, Placebo
Keywords
Tadalafil, Phosphodiesterase 5 Inhibitors, Cyclic Guanylyl Monophosphate Pathway, Pharmacologic Actions, Vasodilator Agents, Cardiovascular Agents, Obesity, Glycemic Traits, Insulin Resistance, Glucose Metabolism
Medical subject headings
Cardiovascular Diseases, Insulin Resistance, Glucose Intolerance, Obesity

What participants receive

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

  • TadalafilDrug

    Also called Adcirca, Cialis

    20 mg Tadalafil taken once a day for 3 months

  • PlaceboDrug

    Also called Sugar pill

    Placebo tablet taken by mouth once a day for 3 months

Study groups in NCT01444651
Study groupRoleWhat they receive
TadalafilActive comparator20 mg Tadalafil tablet taken by mouth once a day for 3 months
Receives: Drug: Tadalafil
PlaceboPlacebo comparatorPlacebo tablet taken by mouth once a day for 3 months
Receives: Drug: Placebo

What is being measured

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

  1. Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR

    The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = [fasting glucose * fasting insulin]/405

    Measured: Baseline and 3 months

Secondary outcomes (5)

  1. Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index

    The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 30, 60, 90, 120 min) * (mean insulin at time 30, 60, 90, and 120 min)]

    Measured: Baseline and 3 months

  2. Baseline to 3-month Change in Endothelial Function Measured by EndoPAT

    Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)

    Measured: Baseline and 3 months

  3. Insulinogenic Index

    The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = [fasting insulin - insulin at time 30 min] / [fasting glucose - glucose at time 30 min]

    Measured: Baseline and 3 months

  4. Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index

    The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin

    Measured: Baseline and 3 months

  5. Baseline to 3-month Change in Matsuda Disposition Index

    Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = [Matsuda sensitivity index * insulinogenic index]

    Measured: Baseline and 3 months

Timeline

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

  1. First posted3 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01444651
Sponsor's protocol ID
2010P-001519
Status last verified
Dec 2016
First submitted
3 Aug 2011
Last updated
30 Jan 2017
Data monitoring committee
Yes

Publications

  • Ho JE, Arora P, Walford GA, Ghorbani A, Guanaga DP, Dhakal BP, Nathan DI, Buys ES, Florez JC, Newton-Cheh C, Lewis GD, Wang TJ. Effect of phosphodiesterase inhibition on insulin resistance in obese individuals. J Am Heart Assoc. 2014 Sep 11;3(5):e001001. doi: 10.1161/JAHA.114.001001.

    PubMed 25213566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil in people with Cardiovascular Disease and Insulin Resistance, run by Thomas J. Wang, MD 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 3 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: finished, as of the sponsor's last update on 30 Jan 2017. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jan 2017). 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?

Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR (time frame: Baseline and 3 months). 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 NCT01444651, which also lists 1 linked publication.

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 30 Jan 2017.

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