Phase 2
Completed N=288
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01377844 ↗Enrolled (actual)
288
Serious AEs
5.2%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c at 24 Weeks — -0.28; 0.51 percentage of glycated hemoglobin — p=< 0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c at 24 Weeks |
-0.28; 0.51 | < 0.0001 sig |
| SECONDARY Changes in Systolic and Diastolic Blood Pressure at Week 24 |
-8.62; -3.08; -3.07; -0.40 | < 0.0001 sig |
| SECONDARY Changes in Body Weight at Week 24 |
-2.95; -1.22 | < 0.0001 sig |
| SECONDARY Change From Baseline in HbA1c Over 96 Weeks Time |
-0.10; 0.22; -0.11; 0.49; -0.19; 0.53 | < 0.0001 sig |
| SECONDARY Change From Baseline Over Time in Fasting Plasma Glucose (FPG) |
-1.39; 0.85; -1.23; 1.22; -1.75; 0.67 | < 0.0001 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c <7% |
14; 13; 22; 15; 27; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects ≥18 years old
- Diagnosed with type 2 diabetes
- Body mass index (BMI) ≤ 45 kg/m2
- HbA1c between 7 and 10% (inclusive) at screening
- FPG 160 or diastolic blood pressure >95)
- Not willing to use effective birth control, if female with child-bearing potential
- Life expectancy < 2 years
- New York Heart Association (NYHA) Class 4 heart failure
- Sera positive of HCV, HIV, or positive on drug screen
- Currently participating in another interventional trial
- Previous treatment with EGT0001442 or EGT0001474
- Not able to comply with the study scheduled visits
Data sourced from ClinicalTrials.gov (NCT01377844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.