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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 is a Phase 2 study that has completed, run by Theracos. The registered enrollment target is 288 participants.
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).
Interventions
- DRUG Placebo
- DRUG EGT0001442
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377844
The ClinicalTrials.gov registry entry for NCT01377844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theracos, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01377844 reports 0 study locations.
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.
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