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Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jul 30, 2025 to Jul 29, 2025 Completion date: Jul 30, 2026 to Jul 29, 2026v11 Show 1 more changeShow less
    • Completion date: Jul 30, 2026 to Jul 29, 2026
  2. Primary completion date: Jun 15, 2025 to Jul 30, 2025 Completion date: Jun 15, 2026 to Jul 30, 2026v10 Show 1 more changeShow less
    • Completion date: Jun 15, 2026 to Jul 30, 2026
  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Apr 30, 2025 to Jun 15, 2025 · Completion date: Mar 31, 2026 to Jun 15, 2026 · Site details revised at 2 of 2 sitesv9 Show 3 more changesShow less
    • Primary completion date: Apr 30, 2025 to Jun 15, 2025
    • Completion date: Mar 31, 2026 to Jun 15, 2026
    • Site details revised at 2 of 2 sites
  4. Primary completion date: Sep 30, 2024 to Apr 30, 2025 Completion date: Mar 31, 2025 to Mar 31, 2026v8 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Mar 31, 2026
  5. Lead sponsor: University of Virginia to University of Alabama at Birmingham Collaborators expanded, about 10 wordsv7 Show 1 more changeShow less
    • Collaborators expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 2 Primary completion date: Jun 30, 2024 to Sep 30, 2024 · Completion date: Jul 31, 2024 to Mar 31, 2025v6 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2024 to Sep 30, 2024
    • Completion date: Jul 31, 2024 to Mar 31, 2025
  2. Primary completion date: Mar 2023 to Jun 30, 2024 Completion date: Jun 2023 to Jul 31, 2024 · Study site revisedv5 Show 2 more changesShow less
    • Completion date: Jun 2023 to Jul 31, 2024
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Start date changed from estimate of Mar 2022 to Mar 7, 2022 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  4. Primary completion date: Dec 2022 to Mar 2023 Completion date: Mar 2023 to Jun 2023 · Start date: Feb 2022 to Mar 2022v3 Show 2 more changesShow less
    • Completion date: Mar 2023 to Jun 2023
    • Start date: Feb 2022 to Mar 2022
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Jan 2022 to Feb 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Jan 2022 to Feb 2022
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05098470
Lead Sponsor University of Alabama at Birmingham
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 2 Diabetes
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov