NCT05098470Active, not recruitingPhase 3
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity on Endogenous Glucose Production in Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Oct 2021
- Start date
- 7 Mar 2022
- Primary completion date
- 29 Jul 2025
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Type 2 diabetes
- NCT number
- NCT05098470
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 7 Mar 2022 to the primary completion date, 29 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Insulin therapy
- SGLT2 inhibitors
- Medications affecting GI motility (e.g., erythromycin, pramlintide).
Other illness
- 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.
Lab values
- Medications that may affect glucose metabolism such as corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, and anticoagulants.
Other
- Long acting GLP-1 analogues
- TZDs
- Pregnancy or breast feeding, or other comorbidities precluding participation.
Who the study is looking for
- BMI:25-40 kg/m2.
- 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).
Age in the registry: 25 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rita Basu Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.