metformin
Drug1500-2000 mg per day for 8 weeks
NCT Number: NCT05098470
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.
This study is active but is not currently recruiting participants.
25 year–80 year
All sexes
Interventional
Phase 3
Rita Basu, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1500-2000 mg per day for 8 weeks
Long-acting insulin for 8 weeks
Oral Glucokinase Activator 75 mg twice daily for 8 weeks
Time frame: 8 weeks
Ratio of GNG to total EGP
Time frame: 8 weeks
Ratio of GLY to total EGP
Time frame: 8 weeks
UDP glucose flux
University of Alabama at Birmingham
Other
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity on Endogenous Glucose Production in Type 2 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05710900
Diabetes Mellitus, Diabetes Mellitus, Type 2
Kelowna, British Columbia, Canada
View Trial DetailsNCT07400653
Body Weight, Diabetes Mellitus
Anaheim, California, United States
View Trial DetailsNCT05040087
Diabetes Mellitus, Diabetes Mellitus, Type 2
Decatur, Georgia, United States
View Trial DetailsNCT05360056
Diabetes Mellitus, Diabetes Mellitus, Type 2
Columbus, Ohio, United States
View Trial Details