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NCT05098470 · ClinicalTrials.gov registry record · Phase 3
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity
A Phase 3 study of Type 2 Diabetes, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05098470: Active Phase 3 study of Type 2 Diabetes, sponsored by University of Alabama at Birmingham.
NCT05098470 is a Phase 3 study of Type 2 Diabetes that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 100 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05098470, a Phase 3 study of Type 2 Diabetes, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Ratio of GNG to total EGP
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Dorzagliatin
- DRUG Insulin Glargine
Study Locations (2)
Alabama
- Rita Basu - Birmingham
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-07-29 |
| Phase | Phase 3 |
What the registry record for NCT05098470 still lists
NCT05098470 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Metformin is the first listed.
NCT05098470 reports a single indexed study location in Alabama, Virginia.
Frequently Asked Questions
What is clinical trial NCT05098470 about?
NCT05098470 is a clinical study titled "Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity". 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 diabete...
What is the current status of trial NCT05098470?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-03-07. Estimated completion is 2026-07-29.
What conditions does trial NCT05098470 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT05098470?
The interventions under investigation include: Metformin (DRUG), Dorzagliatin (DRUG), Insulin Glargine (DRUG).
Who is sponsoring clinical trial NCT05098470?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05098470 being conducted?
This trial has 2 study locations across Alabama, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05098470's enrollment target sits among peer trials
100 152nd of 327 higher than 166 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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