The effect of selective PDE-5 inhibition on capillary recruitment, glucose uptake and endothelial function following a mixed meal in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003921-25-SE

Enrollment

Registered

2009-05-11

Start date

2009-07-27

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Our primary objective is to elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. Our secondary objective is to elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity. MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin

Interventions

Trade Name: Cialis Product Name: Cialis Product Code: LY450190 Pharmaceutical Form: Tablet Other descriptive name: TADALAFIL Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be acceptable for the study the type 2 diabetic subjects have to fulfill the following criteria: 1) Post-menopausal state, defined as natural amenorrhea for at least 12 months, age 52-67 yr or males 40-65 years; 2) Type 2 diabetes diagnosed or indicated by fasting or 2-hr OGTT plasma glucose levels (diabetes duration =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Subjects with concurrent use of nitrates or NO donors, history of coronary heart or cerebrovascular disease, cardiac failure (stages NYHA II-IV), uncontrolled hypertension, significant diabetic complications, and inadequate glycemic control (HbA1c > 6.5%, ref values: 3.5-5.3%) will be excluded; 2) Patients on glitazones, insulin, beta-blockers, ACE-inhibitors, Angiotensin II Receptor subtype 1 Blocker or corticosteroids will be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: To elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. ;Secondary Objective: To elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity. ;Primary end point(s): The primary endpoints are PS for glucose in muscle and uptake of glucose in the brachioradialis muscle following a mixed meal as well as Area Under the Curve (AUC) for plasma glucose following the meal. If the data suggest an enhanced glucose uptake induced by tadalafil there may be a new indication for the drug. The secondary endpoint will be to estimate the effects of tadalafil on indices of arterial stiffness.	—

Measure

Time frame

Main Objective: To elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. ;Secondary Objective: To elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity. ;Primary end point(s): The primary endpoints are PS for glucose in muscle and uptake of glucose in the brachioradialis muscle following a mixed meal as well as Area Under the Curve (AUC) for plasma glucose following the meal. If the data suggest an enhanced glucose uptake induced by tadalafil there may be a new indication for the drug. The secondary endpoint will be to estimate the effects of tadalafil on indices of arterial stiffness.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026