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NCT00228904
Effects of Pulsatile IV Insulin Delivery on Peripheral Diabetic Neuropathy
Phase 2/Phase 3 trial testing Placebo in Diabetic Neuropathy. Withdrawn.
1 May 2011
Quick facts
| Lead sponsor | Florida Atlantic University |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 1 February 2005 |
| Primary completion | 1 May 2011 |
| Estimated completion | 1 October 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo
- Pulsatile IV insulin delivery (humalog, humulin, novolog)
Conditions studied
- Diabetic Neuropathy — all drugs for Diabetic Neuropathy →
Sponsor
Florida Atlantic University
Who can join
Adults 20 to 90, any sex, with Diabetic Neuropathy. 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 evaluate objective testing performed including nerve conduction velocity in diabetic patients treated with pulsatile intravenous insulin therapy
Time frame: at baseline and every six months
Sponsor's own description
Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin therapy in affected patients otherwise resistant to all conventional therapies. Significant complications produce painful peripheral dysesthesias, loss of sensation and gastroparesis. This study is designed to test the effectiveness of pulsatile IV insulin therapy on diabetic neuropathy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00228904
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Florida Atlantic University 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 NCT00228904 (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 Florida Atlantic University
- Last refreshed: 8 August 2016
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/NCT00228904.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing