Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
It has been shown that individuals with type 2 diabetes have higher blood sugar throughout
the night than individuals without type 2 diabetes. However, it is still unknown if this rise
in blood sugar can be controlled using medications.
This study will examine the effects of three different diabetes treatments to determine if
they improve night time blood sugars. Participants will be randomly assigned for 8 weeks to
one of the following three groups:
GROUP 1: Insulin. Participants will be instructed on self-injecting insulin glargine
once-daily in the morning. The dose will be increased by the study team to avoid episodes of
low blood sugar and to maintain fasting blood sugar concentrations between 70 to 180 mg/dl.
GROUP 2: Metformin. Participants will start the drug (500 mg twice daily) with meals. After
72 hours and in the absence of side effects, they will increase the dose to 500 mg with
breakfast and 1,000 mg with supper. After a further 72 hours and in the absence of side
effects, they will increase the dose to 1,000 mg twice daily with meals and continue until
the end of the trial. The dose will be adjusted by the study team to maintain fasting blood
sugar concentrations between 70 to 180 mg/dl.
GROUP 3: Dorzagliatin. This medication dose will be 75 mg twice daily. The investigators
anticipate fasting glucose concentrations will be between 70 to 180 mg/dl since the dose of
this medication cannot be titrated.