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NCT05054842
Efficacy and Safety of Retagliptin Phosphate in Combination With Metformin in Type 2 Diabetic Subjects With Poor Metformin Glycemic Control: a Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Design
Phase 3 trial testing Retagliptin phosphate tablets、metformin sustained-release tablets in Type 2 Diabetes in 174 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 174 |
| Start date | 6 December 2021 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Retagliptin phosphate tablets、metformin sustained-release tablets — full drug profile →
- Retagliptin phosphate placebo tablets、metformin sustained-release tablets
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in HbA1c relative to baseline
Time frame: After 16 weeks of treatment
Sponsor's own description
Retagliptin phosphate tablet is a DPP IV inhibitor durg,study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin for 16 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Signaling pathways and intervention for therapy of type 2 diabetes mellitus.
Cao R, Tian H, Zhang Y, Liu G, et al · · 2023 · cited 30× · PMID 37303813 · DOI 10.1002/mco2.283
Verify or expand the search:
- PubMed search for NCT05054842
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · 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 NCT05054842 (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 Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 7 July 2023
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/NCT05054842.
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