This study is to evaluate the efficacy and safety of oral insulin in patients with Type 2 Diabetes Mellitus. With the study, we can focus on how there are no injections needed which could help individuals with needle phobias.
- Male and female subjects aged 18 and older.
- Established diagnosis of Type 2 Diabetes for at least 6 months , with A1C ≥ 7.5%.
- Stable dose of metformin (at least 1500 mg or maximal tolerated dose) for a period of at least 3 months.
- Taking metformin only or metformin in addition to no more than two of the following: DPP-4, SGLT-2, or TZD.
- Body mass index (BMI) of up to 40, with no more than 5 kg gain or loss in the 3 months prior to Screening.
- Renal function – eGFR > 30 ml/min/1.73 m2
- Females of childbearing potential must have a negative serum pregnancy test result at Screening.