Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
Completed
Theracos
Phase 2
2011-12-01
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).
A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
Completed
Theracos
Phase 2
2015-05-12
The purpose of this study was to investigate the effect of bexagliflozin in lowering
hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin
is an orally administered drug for the treatment of T2DM and is classified as a Sodium
Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and
those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320
subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or
placebo, once daily for 12 weeks in an outpatient setting.
The purpose of this study is to investigate the effect of bexagliflozin in lowering
hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased
risk of cardiovascular adverse events.
The data from this study will be combined with the data from other bexagliflozin studies in a
meta-analysis of CV safety outcomes.
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