NCT05098470

Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity on Endogenous Glucose Production in Type 2 Diabetes

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin	1500-2000 mg per day for 8 weeks
DRUG	Insulin Glargine	Long-acting insulin for 8 weeks
DRUG	Dorzagliatin	Oral Glucokinase Activator 75 mg twice daily for 8 weeks

Timeline

• Start date: 2022-03-07
• Primary completion: 2025-07-29
• Completion: 2026-07-29
• First posted: 2021-10-28
• Last updated: 2025-07-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study