Last reviewed · How we verify
NCT01000922
A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes
Phase 2 trial testing Regular Human Insulin in Diabetes Mellitus in 24 participants. Completed in 1 January 2008.
1 January 2008
Quick facts
| Lead sponsor | Biodel |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 June 2006 |
| Primary completion | 1 January 2008 |
| Estimated completion | 1 January 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Regular Human Insulin — full drug profile →
- Lispro — full drug profile →
- VIAject
- VIAject 50% — full drug profile →
- VIAject/Insulin Glargine — full drug profile →
- Insulin Glargine/VIAject — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
Biodel — full company profile →
Who can join
Adults 19 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.
-
To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments
Time frame: 8 hours
Sponsor's own description
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
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 NCT01000922
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Regular Human Insulin
Trials testing the same drug.
- NCT02415556 — Memory Aid by Intranasal Insulin in Diabetes (MemAID) · Phase 2 · completed
Other recruiting trials for Diabetes Mellitus
Currently open trials in the same condition.
- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
- NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
- NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · 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 NCT01000922 (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: 28 July 2015
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/NCT01000922.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing