A Trial of Tadalafil and Glycemic Traits

NCT01444651 | Completed Phase 3 Results DMC

• 1 other identifier: 2010P-001519
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiovascular Disease; Insulin Resistance; Glucose Intolerance; Obesity

Keywords

Tadalafil; Phosphodiesterase 5 Inhibitors; Cyclic Guanylyl Monophosphate Pathway; Pharmacologic Actions; Vasodilator Agents; Cardiovascular Agents; Obesity; Glycemic Traits; Insulin Resistance; Glucose Metabolism

Outcome Measures

Primary Outcomes (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

  Baseline and 3 months

Secondary Outcomes (5)

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

  Baseline and 3 months

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

  Baseline and 3 months

• Insulinogenic Index

  Baseline and 3 months

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

  Baseline and 3 months

• Baseline to 3-month Change in Matsuda Disposition Index

  Baseline and 3 months

Study Arms (2)

Tadalafil

ACTIVE COMPARATOR

20 mg Tadalafil tablet taken by mouth once a day for 3 months

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Placebo tablet taken by mouth once a day for 3 months

Drug: Placebo

Interventions

Tadalafil DRUG

20 mg Tadalafil taken once a day for 3 months

Also known as: Adcirca, Cialis

Tadalafil

Placebo DRUG

Placebo tablet taken by mouth once a day for 3 months

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Thomas J. Wang, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Related Publications (1)

• 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.

  PMID: 25213566 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Insulin Resistance; Glucose Intolerance; Obesity

Interventions

Tadalafil; Sugars

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Carbohydrates

Results Point of Contact

• Title: Dr. Jennifer Ho
• Organization: Massachusetts General Hospital

jho1@partners.org

617-726-6411

Study Officials

• Thomas J Wang, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: October 3, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 30, 2017
• Results First Posted: January 30, 2017

Record last verified: 2016-12

Locations

US (1)