Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity
NCT ID: NCT05098470
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-03-07
2026-07-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Metformin
Metformin
1500-2000 mg per day for 8 weeks
Insulin Glargine
Insulin Glargine
Long-acting insulin for 8 weeks
Dorzagliatin
Dorzagliatin
Oral Glucokinase Activator 75 mg twice daily for 8 weeks
Interventions
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Metformin
1500-2000 mg per day for 8 weeks
Insulin Glargine
Long-acting insulin for 8 weeks
Dorzagliatin
Oral Glucokinase Activator 75 mg twice daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* HbA1C ≤ 9% on lifestyle therapy with or without monotherapy with metformin or sulphonylureas (SU); or combination therapies (metformin and SU, DPPIV inhibitors, only short acting GLP-1 analogues exenatide (Byeta) and liraglutide (Victoza).
Exclusion Criteria
* SGLT2 inhibitors
* Long acting GLP-1 analogues
* TZDs
* Medications affecting GI motility (e.g., erythromycin, pramlintide).
* Medications that may affect glucose metabolism such as corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, and anticoagulants.
* Unstable diabetic retinopathy, microalbuminuria, macrovascular disease.
* Upper GI disorder/surgery, debilitating chronic disease, anemia, and symptoms of undiagnosed illnesses.
* History of alcoholism or substance abuse.
* Pregnancy or breast feeding, or other comorbidities precluding participation.
25 Years
80 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Rita Basu
Professor of Medicine
Locations
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Rita Basu
Birmingham, Alabama, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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210395
Identifier Type: -
Identifier Source: org_study_id
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