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NCT01908894
A Double-blind Study of the Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
Phase 1 trial testing BIOD-123 in Diabetes Mellitus in 12 participants. Completed in 1 March 2012.
1 March 2012
Quick facts
| Lead sponsor | Biodel |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 February 2012 |
| Primary completion | 1 March 2012 |
| Estimated completion | 1 March 2012 |
Drugs / interventions tested
- BIOD-123 — full drug profile →
- BIOD-125 — full drug profile →
- Humalog (INSULIN LISPRO) — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
Biodel — full company profile →
Who can join
Adults 18 to 70, any sex, with Diabetes Mellitus. 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.
-
Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog.
Time frame: 0-30, 0-60, 0-90, 0-480, and 120-480 minutes
Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months.
Sponsor's own description
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
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 NCT01908894
- 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 NCT01908894 (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 Biodel
- Last refreshed: 24 July 2013
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/NCT01908894.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing