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NCT00239148
A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Effects of Repeated Subcutaneous Doses of E1 in Combination With G1 in Type 1 Diabetes
Phase 1 trial testing E1 and G1 in Type 1 Diabetes in 20 participants. Completed in 1 December 2006.
Quick facts
| Lead sponsor | OPKO Health, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 June 2005 |
| Estimated completion | 1 December 2006 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- E1 and G1 — full drug profile →
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
OPKO Health, Inc. — full company profile →
Who can join
Adults 18 to 40, any sex, with Type 1 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.
- To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes
Sponsor's own description
The purpose of the study is to determine whether E1 and G1 are safe and effective in the treatment of type 1 diabetes. Type 1 diabetes is an autoimmune disease, in which the immune system attacks pancreatic beta cells. These cells produce insulin, which regulates blood glucose. The mainstay of current treatment for type 1 diabetes is dietary control and daily parenteral administration of insulin. Recent diabetes research has increasingly focused on pancreatic islet cell replacement, either by islet cell transplantation or by endogenous regeneration of islet cells. During fetal development, islet precursor cells proliferate and differentiate into mature beta cells capable of producing insulin. This process is known as islet cell neogenesis. Islet cell neogenesis normally ceases around birth, however, the adult pancreas still retains significant potential for islet regeneration, as shown by tissue repair following pancreatic injury. Pre-clinical studies have shown that E1 and G1 can re-establish islet cell neogenesis and increase pancreatic insulin production in diabetic animal models. It is therefore postulated that treatment with E1 and G1 may produce islet cell regeneration in type 1 diabetic patients.
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 NCT00239148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes
Currently open trials in the same condition.
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- NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Other OPKO Health, Inc. trials
Trials by the same sponsor.
- NCT05543928 — Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism · Phase 3 · terminated
- NCT04551911 — Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 · Phase 2 · completed
- NCT04063644 — Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients · NA · completed
- NCT03810664 — A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations · Phase 1 · completed
- NCT03660800 — Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Hea · Phase 1 · completed
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 NCT00239148 (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 OPKO Health, Inc.
- Last refreshed: 17 October 2019
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/NCT00239148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing