Trial · NCT01444651
A Trial of Tadalafil and Glycemic Traits
NCT01444651, Phase 3, Completed, Thomas J. Wang, MD; results first posted 2017-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Tadalafil and Glycemic Traits. Trials, record NCT01444651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01444651
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Tadalafil and Glycemic Traits
- NCT number
- NCT01444651
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 73 participants, actual
- Lead sponsor
- Thomas J. Wang, MD
- Conditions
- Cardiovascular Disease, Insulin Resistance, Glucose Intolerance, Obesity
- Interventions
- Tadalafil, Placebo
- First posted
- 2011-10-03
- Last updated
- 2017-01-30
- Results first posted
- 2017-01-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Baseline and 3 months | 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 |
| Secondary | Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Baseline and 3 months | 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 \[fasting glucose\*fasting insulin\* (mean glucose from time 30, 60, 90, 120 min) \* (mean insulin at time 30, 60, 90, and 120 min)\] |
| Secondary | Baseline to 3-month Change in Endothelial Function Measured by EndoPAT | Baseline and 3 months | 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) |
| Secondary | Insulinogenic Index | Baseline and 3 months | 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 = \[fasting insulin - insulin at time 30 min\] / \[fasting glucose - glucose at time 30 min\] |
| Secondary | Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index | Baseline and 3 months | 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 |
| Secondary | Baseline to 3-month Change in Matsuda Disposition Index | Baseline and 3 months | 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 = \[Matsuda sensitivity index \* insulinogenic index\] |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Baseline and 3 months | mg*microunits/dL*mL | MEAN | |
| SECONDARY | Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Baseline and 3 months | unitless index | MEAN | |
| SECONDARY | Baseline to 3-month Change in Endothelial Function Measured by EndoPAT | Baseline and 3 months | unitless index | MEAN | |
| SECONDARY | Insulinogenic Index | Baseline and 3 months | unitless index | MEAN | |
| SECONDARY | Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index | Baseline and 3 months | unitless index | MEAN | |
| SECONDARY | Baseline to 3-month Change in Matsuda Disposition Index | Baseline and 3 months | unitless index | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Tadalafil | Baseline | 3.57 | Standard Deviation 2.86 | mg*microunits/dL*mL |
| Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Placebo | Baseline | 3.84 | Standard Deviation 3.80 | mg*microunits/dL*mL |
| Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Tadalafil | 3 months | 3.81 | Standard Deviation 5.14 | mg*microunits/dL*mL |
| Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR | Placebo | 3 months | 5.06 | Standard Deviation 3.95 | mg*microunits/dL*mL |
| Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Tadalafil | Baseline | 3.60 | Standard Deviation 2.54 | unitless index |
| Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Placebo | Baseline | 3.51 | Standard Deviation 2.15 | unitless index |
| Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Tadalafil | 3 months | 4.27 | Standard Deviation 2.83 | unitless index |
| Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index | Placebo | 3 months | 3.28 | Standard Deviation 2.42 | unitless index |
| Baseline to 3-month Change in Endothelial Function Measured by EndoPAT | Tadalafil | Baseline | 2.1 | Standard Deviation 0.5 | unitless index |
| Baseline to 3-month Change in Endothelial Function Measured by EndoPAT | Placebo | Baseline | 2.3 | Standard Deviation 0.6 | unitless index |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tadalafil | 36 | |
| Overall Study | STARTED | Placebo | 37 | |
| Overall Study | COMPLETED | Tadalafil | 25 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Tadalafil | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Vascular disorders | Tadalafil | 4 | 36 | |
| other | Headache | Vascular disorders | Placebo | 0 | 37 | |
| other | Blurry vision and headache | Vascular disorders | Tadalafil | 0 | 36 | |
| other | Blurry vision and headache | Vascular disorders | Placebo | 1 | 37 | |
| other | Back or leg pain | Musculoskeletal and connective tissue disorders | Tadalafil | 2 | 36 | |
| other | Back or leg pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 37 | |
| other | Headache and back ache | Musculoskeletal and connective tissue disorders | Tadalafil | 1 | 36 | |
| other | Headache and back ache | Musculoskeletal and connective tissue disorders | Placebo | 0 | 37 | |
| other | arm pain | Musculoskeletal and connective tissue disorders | Tadalafil | 0 | 36 | |
| other | arm pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 37 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tadalafil | 7 | 36 |
| Total, other adverse events | Placebo | 2 | 37 |
| Total, serious adverse events | Tadalafil | 0 | 36 |
| Total, serious adverse events | Placebo | 0 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25213566 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tadalafil vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01444651
GET https://conductscience.org/api/trials/v1/NCT01444651/results?page=2