Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

Last updated: April 28, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Metformin

Dorzagliatin

Insulin Glargine

Clinical Study ID

NCT05098470
210395
R01DK029953
  • Ages 25-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI:25-40 kg/m2.

  • HbA1C ≤ 9% on lifestyle therapy with or without monotherapy with metformin orsulphonylureas (SU); or combination therapies (metformin and SU, DPPIV inhibitors,only short acting GLP-1 analogues exenatide (Byeta) and liraglutide (Victoza).

Exclusion

Exclusion Criteria:

  • Insulin therapy

  • 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, andanticoagulants.

  • Unstable diabetic retinopathy, microalbuminuria, macrovascular disease.

  • Upper GI disorder/surgery, debilitating chronic disease, anemia, and symptoms ofundiagnosed illnesses.

  • History of alcoholism or substance abuse.

  • Pregnancy or breast feeding, or other comorbidities precluding participation.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Metformin
Phase: 3
Study Start date:
March 07, 2022
Estimated Completion Date:
June 15, 2026

Connect with a study center

  • Rita Basu

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Rita Basu

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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