A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2, Hypertension
In brief
To evaluate the impact of escalating doses of IW-1973 on endothelial function \[using EndoPAT to measure fingertip small vessel pulse volume\], blood pressure (BP), and heart rate.
Key facts
- Study ID
- NCT02906579
- Run by
- Cyclerion Therapeutics
- People needed
- 11
- Starts
- 2016-09-01
- Expected to finish
- 2017-03-17
- Last updated by the study team
- 2020-04-16
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient is ambulatory male or female
- Patient's body mass index score is >20 and <40 kg/m2 at the Screening Visit
- Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
- Patient's health is stable with no clinically significant findings on a physical examination
- Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, and an entry HbA1c that does not mandate prompt intervention for improved control
- Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit and BP within the protocol's acceptable range
- Patients must be on a stable regimen for glycemic control, and a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
- Patient has abnormal endothelial function measured by the EndoPAT
- Other inclusion criteria per protocol
You may not qualify if…
- Patient has a clinically significant active or unstable medical condition that, in the opinion of the Investigator, would preclude trial participation
- Patient is on medication(s) that when co-administered with a soluble guanylate cyclase (sGC) stimulator, could increase the risk of hypotension
- Patient has evidence of severe or active end-organ damage attributable to diabetes
- Patient has severe renal insufficiency, has undergone renal transplantation, or has planned renal transplantation
- Other exclusion criteria per protocol
Where it is running
- ICON Early Phase Unit — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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