Phase 3
Completed N=73
A Trial of Tadalafil and Glycemic Traits
Source: ClinicalTrials.gov NCT01444651 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR — 3.57; 3.84; 3.81; 5.06 mg*microunits/dL*mL — p=0.34
◆ Published Evidence
Established
38citations · ~3 / year
Effect of phosphodiesterase inhibition on insulin resistance in obese individuals.
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. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).
Linked Publications
-
Effect of phosphodiesterase inhibition on insulin resistance in obese individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR |
3.57; 3.84; 3.81; 5.06 | 0.34 |
| SECONDARY Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index |
3.60; 3.51; 4.27; 3.28 | 0.18 |
| SECONDARY Baseline to 3-month Change in Endothelial Function Measured by EndoPAT |
2.1; 2.3; 2.1; 2.2 | 0.76 |
| SECONDARY Insulinogenic Index |
0.39; 2.17; 2.62; 1.04 | 0.06 |
| SECONDARY Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index |
1.74; 2.87; 4.48; 0.58 | 0.009 sig |
| SECONDARY Baseline to 3-month Change in Matsuda Disposition Index |
2.23; 6.67; 9.22; 0.19 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years and 30 kg/m2
- Fasting insulin > 10 uU/mL
Exclusion Criteria
- Systolic blood pressure (SBP) 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
- 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%)
Data sourced from ClinicalTrials.gov (NCT01444651) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.