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NCT03194009: PRuDENTE
PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment
NA trial testing Metformin in Diabetes Mellitus, Type 2 in 3,060 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Instituto Nacional de Salud Publica, Mexico |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 3,060 |
| Start date | 10 August 2017 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Lifestyle intervention
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Prediabetic State — all drugs for Prediabetic State →
Sponsor
Instituto Nacional de Salud Publica, Mexico — full company profile →
Who can join
Adults 30 to 65, any sex, with Diabetes Mellitus, Type 2 or Prediabetic State. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The PRuDENTE study proposes to assess if metformin therapy a viable, efficient and cost-effective intervention to decrease the incidence of type 2 diabetes (DMT2) in adult subjects with obesity and pre-diabetes in Mexico City. Half of the individuals recruited will receive as intervention, metformin and lifestyle modification therapy and the other half will receive only lifestyle modification therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus.
Madsen KS, Chi Y, Metzendorf MI, Richter B, et al · · 2019 · cited 35× · PMID 31794067 · DOI 10.1002/14651858.cd008558.pub2 -
Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).
Rodríguez LA, Barquera S, Aguilar-Salinas CA, Sepúlveda-Amor J, et al · · 2020 · cited 3× · PMID 32580032 · DOI 10.1016/j.cct.2020.106067
Verify or expand the search:
- PubMed search for NCT03194009
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
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- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Instituto Nacional de Salud Publica, Mexico trials
Trials by the same sponsor.
- NCT04629261 — Effects of Bicycle-sharing Program on Health · NA · unknown
- NCT04507100 — Comprehensive Analysis of the Program:Salud Escolar · NA · withdrawn
- NCT03278483 — Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL) · Phase 4 · completed
- NCT06096194 — Vitamin D3-enhanced Eggs in Preschool Children · NA · completed
- NCT05149248 — Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03194009 (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 Instituto Nacional de Salud Publica, Mexico
- Last refreshed: 7 March 2018
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/NCT03194009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing