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NCT01162876
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Phase 3 trial testing saxaglipitin in Diabetes in 20 participants. Completed in 1 November 2010.
1 November 2010
Quick facts
| Lead sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 1 July 2010 |
| Primary completion | 1 November 2010 |
| Estimated completion | 1 November 2010 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- saxaglipitin — full drug profile →
Conditions studied
- Diabetes — all drugs for Diabetes →
Sponsor
Kyowa Kirin Co., Ltd. — full company profile →
Who can join
Adults 20 to 65, any sex, with 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.
-
Pharmacokinetics
Time frame: daily, up to 42days
Concentrations of plasma saxagliptin and BMS-510849 -
Pharmacodynamics
Time frame: daily, up to 42 days
Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration
Sponsor's own description
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.
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 NCT01162876
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kyowa Kirin Co., Ltd. trials
Trials by the same sponsor.
- NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） · Phase 3 · recruiting
- NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
- NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
- NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not 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 NCT01162876 (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 Kyowa Kirin Co., Ltd.
- Last refreshed: 7 March 2017
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/NCT01162876.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing