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NCT04665284: SAFE-PAK
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Phase 4 trial testing Empagliflozin in Type II Diabetes Mellitus in 244 participants. Completed in 28 September 2020.
15 September 2020
Quick facts
| Lead sponsor | Getz Pharma |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 244 |
| Start date | 1 June 2019 |
| Primary completion | 15 September 2020 |
| Estimated completion | 28 September 2020 |
| Sites | 11 locations across Pakistan |
Drugs / interventions tested
- Empagliflozin (empagliflozin) — full drug profile →
- Usual care group — full drug profile →
Conditions studied
- Type II Diabetes Mellitus — all drugs for Type II Diabetes Mellitus →
Sponsor
Getz Pharma — full company profile →
Who can join
Adults 18 to 75, any sex, with Type II Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and efficacy of Empagliflozin in Pakistani Muslim patients with type 2 diabetes (SAFE-PAK); a randomized clinical trial.
Aamir AH, Raja UY, Qureshi FM, Asghar A, et al · · 2022 · cited 1× · PMID 36443769 · DOI 10.1186/s12902-022-01213-1 -
Safety and efficacy of Empagliflozin in Pakistani Muslim Patients with Type 2 Diabetes (SAFE-PAK); A Randomized Clinical Trial
Aamir AH, Raja UY, Qureshi FM, Asghar A, et al · · 2022 · DOI 10.21203/rs.3.rs-1798584/v1
Verify or expand the search:
- PubMed search for NCT04665284
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting
Other recruiting trials for Type II Diabetes Mellitus
Currently open trials in the same condition.
- NCT07495956 — cfMSC Therapy for Diabetes · Phase 1, PHASE2 · recruiting
- NCT07340320 — A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus · Phase 2 · recruiting
- NCT06561126 — Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its · NA · recruiting
- NCT07350694 — Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its · NA · recruiting
- NCT06387550 — Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus · NA · recruiting
Other Getz Pharma trials
Trials by the same sponsor.
- NCT07174297 — Acotiamide vs Itopride in Postprandial Distress Syndrome · Phase 3 · not yet recruiting
- NCT07031141 — Diabetes Foot Africa Region Registry · not yet recruiting
- NCT06706609 — Classification of Adult-onset Diabetes in Five Subgroups in Pakistani Population · not yet recruiting
- NCT05977647 — Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi · Phase 4 · completed
- NCT05644717 — Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD · Phase 4 · recruiting
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 NCT04665284 (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 Getz Pharma
- Last refreshed: 11 December 2020
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/NCT04665284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing