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NCT04091373
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
Phase 1 trial testing cotadutide multidose pen injection in Type 2 Diabetes Mellitus in 36 participants. Completed in 6 March 2020.
6 March 2020
Quick facts
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 27 September 2019 |
| Primary completion | 6 March 2020 |
| Estimated completion | 6 March 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- cotadutide multidose pen injection
- cotadutide multidose pen injection
- cotadutide multidose pen injection
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
MedImmune LLC — full company profile →
Who can join
Adults 18 to 60, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC injection will be administered by a health care provider at a different injection site (arm, thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after dosing (Days 3, 10, and 17).
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 NCT04091373
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other MedImmune LLC trials
Trials by the same sponsor.
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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 NCT04091373 (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 MedImmune LLC
- Last refreshed: 7 April 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/NCT04091373.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing