Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: EGT0001442; Placebo capsules to match EGT0001442
Intervention description: Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.; Segment 1: Not applicable.
Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2

Summary:

      The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose
      after 28 days of treatment in subjects with type 2 diabetes.

      The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the
      effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose
      produced in the body by the urine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.

          -  Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).

          -  HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the
             HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper
             limit of normal for the HbA1c assay is 6.1%.

          -  Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive)
             while on diabetic medications.

          -  Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose
             between 126 and 270 mg/dL (7 - 15 mmol/L).

          -  If taking drugs for diabetes, must be medically able and willing to discontinue
             diabetic medications for the duration of the study.

          -  Female subjects must be surgically sterilized or postmenopausal.

        Exclusion Criteria:

          -  Type 1 diabetes or diabetes treated with insulin injection.

          -  Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin,
             saxagliptin, a sulfonylurea or combination of these.

          -  Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart
             at screening.

          -  Positive results on screen for drugs of abuse.

          -  Previous treatment with an investigational drug within 30 days or 7 half-lives,
             whichever is longer.

          -  Previous treatment with EGT0001474 or EGT0001442.