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NCT01377844 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Theracos.
- Completed
- Registry status
- Phase 2
- Development phase
- 288
- Enrollment target
NCT01377844: Completed Phase 2 study, sponsored by Theracos.
NCT01377844 is a Phase 2 study that has completed, run by Theracos. The registered enrollment target is 288 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377844, a Phase 2 study, has completed, sponsored by Theracos.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 288 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of \< 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
Primary Outcome
Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment
Interventions
- DRUG Placebo
- DRUG EGT0001442
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01377844 record still lists
NCT01377844 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01377844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377844 about?
NCT01377844 is a clinical study titled "Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus". The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the s...
What is the current status of trial NCT01377844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 288 participants. The study started on 2011-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01377844?
The interventions under investigation include: Placebo (DRUG), EGT0001442 (DRUG).
Who is sponsoring clinical trial NCT01377844?
This trial is sponsored by Theracos, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01377844's enrollment target sits among peer trials
288 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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