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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2017-08-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double-Blind

Study Groups

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IW-1973 QD/QD

On Days 1-14: IW-1973 40 mg taken once daily (QD) in morning (AM) and placebo taken QD at night (PM).

Group Type EXPERIMENTAL

IW-1973

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

IW-1973 BID (Twice Daily)/QD

On Days 1-7: IW-1973 20 mg taken in AM and IW-1973 20 mg taken in PM. On Days 8-14: IW-1973 40 mg taken QD in AM and placebo taken QD in PM.

Group Type EXPERIMENTAL

IW-1973

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Placebo

On Days 1-14: Placebo taken in AM and in PM.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Tablet

Interventions

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IW-1973

Oral Tablet

Intervention Type DRUG

Placebo

Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No