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NCT04801199
Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
Phase 3 trial testing CPL-2009-0031 140 mg in Uncontrolled Type 2 Diabetes Mellitus in 355 participants. Completed in 11 February 2021.
13 January 2021
Quick facts
| Lead sponsor | Cadila Pharnmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 355 |
| Start date | 26 January 2020 |
| Primary completion | 13 January 2021 |
| Estimated completion | 11 February 2021 |
| Sites | 12 locations across India |
Drugs / interventions tested
- CPL-2009-0031 140 mg — full drug profile →
- Sitagliptin 100mg — full drug profile →
Conditions studied
- Uncontrolled Type 2 Diabetes Mellitus — all drugs for Uncontrolled Type 2 Diabetes Mellitus →
Sponsor
Cadila Pharnmaceuticals — full company profile →
Who can join
Adults 18 to 65, any sex, with Uncontrolled Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM).
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:
- PubMed search for NCT04801199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04801199 (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 Cadila Pharnmaceuticals
- Last refreshed: 17 August 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/NCT04801199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing