Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension

• Status: Completed
• Trial end date: 2017-08-03
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclerion Therapeutics; Ironwood Pharmaceuticals, Inc.
• Treatments: Praliciguat

Criteria

Inclusion Criteria:

• Patient is ambulatory male or female

• Patient's body mass index score is > 20 and < 40 kg/m^2 at the Screening Visit

• Women of childbearing potential must have a negative pregnancy test at the time of screening and check-in and must agree to use protocol-specified contraception throughout the duration of the study

• Patient's health is stable with no clinically significant findings on physical examination

• Patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, is on a stable glycemic control medication, and protocol specified hemoglobin (Hb)A1c values at the Screening Visit

• Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, and blood pressure (BP) within the protocol's acceptable range

• Patients must be on a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), stable for 28 days

• Other inclusion criteria per protocol

Exclusion Criteria:

• 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 sGC stimulator, could increase the risk of hypotension

• Patient has evidence of severe or active end-organ damage

• Patient is an active smoker or has used any nicotine-containing products (cigarettes, e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months before Check-in. Use of nicotine is excluded during the study until after the End of Trial Visit.

• Other exclusion criteria per protocol