Who is sponsoring NCT04659915?

NCT04659915 is sponsored by Eleonora Seelig.

What drugs are being tested in NCT04659915?

Interventions in NCT04659915: Metformin 500 mg Oral Tablets + Prednisone 20mg Tablets, Placebo 500 mg Tablets + Prednisone 20mg Tablets.

What condition does NCT04659915 study?

NCT04659915 studies Glucocorticoid Effect.

Is NCT04659915 still recruiting?

NCT04659915 is currently completed. Last updated 23 September 2021.

Last reviewed 2021-09-23 · How we verify

NCT04659915: Gluco-Met

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

Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin

Completed Phase 4 Last updated 23 September 2021

What this trial tests

Phase 4 trial testing Metformin 500 mg Oral Tablets + Prednisone 20mg Tablets in Glucocorticoid Effect in 19 participants. Completed in 18 August 2021.

Timeline

25 February 2021

Primary endpoint
18 August 2021

18 August 2021

Quick facts

Lead sponsor	Eleonora Seelig
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	19
Start date	25 February 2021
Primary completion	18 August 2021
Estimated completion	18 August 2021
Sites	1 location across Switzerland

Drugs / interventions tested

Metformin 500 mg Oral Tablets + Prednisone 20mg Tablets — full drug profile →
Placebo 500 mg Tablets + Prednisone 20mg Tablets — full drug profile →

Conditions studied

Glucocorticoid Effect — all drugs for Glucocorticoid Effect →

Sponsor

Eleonora Seelig — full company profile →

Who can join

Adults 18 to 40, male only, with Glucocorticoid Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Supraphysiological doses of glucocorticoids (GCs) are widely prescribed as immunosuppressants and metabolic side effects such as obesity and diabetes are extremely common. Efforts to investigate and prevent these side effects are lacking. The antidiabetic drug metformin was shown in previous studies to prevent deterioration of glucose homeostasis during GC therapy in patients. However, mechanisms of metformin counteracting GC-induced side effects remain poorly understood. In a randomized, placebo-controlled, cross-over study, 18 healthy volunteers will receive a 7-day course of prednisone with metformin or placebo. Established methods will be used to assess systemic changes in energy homeostasis and novel techniques such as metabolomics will identify underlying pathways. This will advance the understanding of energy homeostasis during GC excess, may prevent thousands of patients from GC-induced side effects and also offers a model for targeting disrupted endogenous GCs secretion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Short-term Metformin Protects Against Glucocorticoid-Induced Toxicity in Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial.
Thierry S, Peterson CJ, Pfammatter S, Tardio PA, et al · · 2025 · cited 3× · PMID 39899467 · DOI 10.2337/dc24-2039

Verify or expand the search:

Other Eleonora Seelig trials

Trials by the same sponsor.

NCT06724692 — Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals · NA · completed
NCT06556277 — Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake · NA · completed
NCT05919992 — The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation (Gluco-Starve) · EARLY_PHASE1 · completed
NCT05167084 — Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals · EARLY_PHASE1 · completed
NCT04482738 — Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects · 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 NCT04659915 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eleonora Seelig
Last refreshed: 23 September 2021

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/NCT04659915.

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