A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.

This is a double-blind, placebo-controlled, 2-period cross-over study conducted at a single study centre to assess the pharmacokinetics and pharmacodynamics (ie, glucose lowering effect) of metformin in participants with T2DM when metformin is administered alone and in combination with multiple doses of AZD6793. This study will consist of 2 treatment periods separated by a washout period of 7 to 14 days.

Approximately 28 eligible participants will be randomized to study intervention such that 24 evaluable participants complete the study (12 participants in each treatment sequence).

Inclusion Criteria:

• Physician-diagnosis of T2DM
• On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
• stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
• HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
• Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.

Exclusion Criteria:

• Physician diagnosis of type 1 diabetes.
• History of any clinically important disease or disorder.
• History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
• History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
• History of prior episode(s) of lactic acidosis.