NCT05559515 (NDPP-Flex) is a NA clinical trial of NDPP-Flex in PreDiabetes, sponsored by Denver Health and Hospital Authority.

Who is sponsoring NCT05559515?

NCT05559515 is sponsored by Denver Health and Hospital Authority.

What drugs are being tested in NCT05559515?

Interventions in NCT05559515: NDPP-Flex, NDPP.

What condition does NCT05559515 study?

NCT05559515 studies PreDiabetes.

Is NCT05559515 still recruiting?

NCT05559515 is currently completed. Last updated 14 November 2025.

Last reviewed 2025-11-14 · How we verify

NCT05559515: NDPP-Flex

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Patient-centered Goal Setting in the National Diabetes Prevention Program

Completed NA Last updated 14 November 2025

What this trial tests

NA trial testing NDPP-Flex in PreDiabetes in 214 participants. Completed in 15 October 2025.

Timeline

1 February 2023

Primary endpoint
4 June 2025

15 October 2025

Quick facts

Lead sponsor	Denver Health and Hospital Authority
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	214
Start date	1 February 2023
Primary completion	4 June 2025
Estimated completion	15 October 2025
Sites	1 location across United States

Drugs / interventions tested

NDPP-Flex
NDPP

Conditions studied

PreDiabetes — all drugs for PreDiabetes →

Sponsor

Denver Health and Hospital Authority

Who can join

Adults 18 to 85, female only, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have \>95% power to detect anticipated treatment effects of \~0.2% A1C improvement and \~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for PreDiabetes

Currently open trials in the same condition.

NCT06897982 — Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center · NA · recruiting
NCT06967558 — The Role of Islet GLP-1 in the Pathogenesis of Prediabetes · Phase 2 · recruiting
NCT06482944 — Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes · NA · recruiting
NCT06989164 — Post Prandial Individual Responses to Different Foods · NA · recruiting
NCT07254572 — Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes · Phase 4 · recruiting

Other Denver Health and Hospital Authority trials

Trials by the same sponsor.

NCT07435662 — Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver · NA · recruiting
NCT06496035 — Blood Flow Restriction Training in Patients With Lower Extremity Fractures · NA · recruiting
NCT06274359 — Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities · NA · terminated
NCT07223918 — Personalized Decision-Aid to Guide Tracheostomy and Prolonged Mechanical Ventilation Decision-Making · completed
NCT05603481 — CGM in Patients With ED's · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05559515 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Denver Health and Hospital Authority
Last refreshed: 14 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05559515.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing