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Anti-diabetic agent

Diabetes Medications for Type 2 Diabetes

Phase 3
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HbA1C ≤ 9% on lifestyle therapy with or without monotherapy with metformin or sulphonylureas (SU)
HbA1C ≤ 9% on combination therapies (metformin and SU, DPPIV inhibitors, only short acting GLP-1 analogues exenatide (Byeta) and liraglutide (Victoza)
Must not have
Insulin therapy
Long acting GLP-1 analogues
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial will test the effects of three different diabetes treatments on blood sugar levels at night.

Who is the study for?
This trial is for adults with type 2 diabetes who have a BMI between 25-40, an HbA1C of ≤9%, and are on specific diabetes medications or lifestyle therapy. It's not for those taking drugs that affect blood sugar, have unstable diabetic eye disease, kidney issues, heart problems, GI disorders/surgery, severe chronic diseases, anemia or undiagnosed symptoms. Pregnant/breastfeeding individuals and those on insulin or certain other medications can't join.Check my eligibility
What is being tested?
The study tests three treatments to manage night time blood sugars in type 2 diabetes over eight weeks: Insulin Glargine injected once daily; Metformin taken twice daily with meals; Dorzagliatin also taken twice daily. Participants will be randomly assigned to one group and doses adjusted to maintain safe fasting blood sugar levels.See study design
What are the potential side effects?
Potential side effects include low blood sugar episodes (especially with insulin), digestive issues like nausea or diarrhea (common with metformin), potential allergic reactions, and injection site reactions for insulin users. Dorzagliatin may cause similar side effects but its profile is less well-known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HbA1C is 9% or lower, and I'm on a diet, exercise plan, metformin, or SU.
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My HbA1C is 9% or lower and I'm on specific diabetes medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on insulin therapy.
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I am taking long-acting GLP-1 analogues.
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I do not have unstable diabetic eye issues, kidney problems, or major blood vessel diseases.
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I am not taking medications that affect stomach or bowel movements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP)
Secondary outcome measures
Contribution of glycogenolysis (GLY) to EGP
Glucokinase activity

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: DorzagliatinExperimental Treatment1 Intervention
Group II: Insulin GlargineActive Control1 Intervention
Group III: MetforminActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dorzagliatin
2017
Completed Phase 2
~90

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Insulin glargine is a long-acting insulin that helps facilitate glucose uptake into cells, thereby lowering blood sugar levels. Metformin decreases hepatic glucose production and increases insulin sensitivity, making it easier for the body to use insulin effectively. Dorzagliatin enhances glucokinase activity, which plays a crucial role in glucose metabolism by facilitating the conversion of glucose to glucose-6-phosphate, thus improving blood sugar control. These mechanisms are vital for Type 2 Diabetes patients as they address different aspects of glucose regulation, helping to maintain stable blood sugar levels and reduce the risk of complications associated with diabetes.
Potential for combination of dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2 inhibitors for the treatment of type 2 diabetes.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,002 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,820 Total Patients Enrolled
University of VirginiaLead Sponsor
761 Previous Clinical Trials
1,255,938 Total Patients Enrolled

Media Library

Dorzagliatin (Anti-diabetic agent) Clinical Trial Eligibility Overview. Trial Name: NCT05098470 — Phase 3
Type 2 Diabetes Research Study Groups: Dorzagliatin, Insulin Glargine, Metformin
Type 2 Diabetes Clinical Trial 2023: Dorzagliatin Highlights & Side Effects. Trial Name: NCT05098470 — Phase 3
Dorzagliatin (Anti-diabetic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098470 — Phase 3
~7 spots leftby Sep 2024