What side effects are associated with this type of intervention?

Insulin glargine can cause hypoglycemia, weight gain, and injection site reactions. Metformin often leads to gastrointestinal issues like nausea, diarrhea, and abdominal discomfort, with a rare risk of lactic acidosis in patients with kidney impairment. Dorzagliatin may have side effects similar to other glucose-lowering medications, including hypoglycemia and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for Type 2 Diabetes include insulin glargine, which facilitates glucose uptake into cells, and metformin, which decreases hepatic glucose production and increases insulin sensitivity. Additionally, GLP-1 receptor agonists like liraglutide and exenatide, which enhance insulin secretion and improve glycemic control, have also been approved. These treatments offer various mechanisms to manage blood glucose levels effectively.

What other types of research exist?

Promising novel alternatives for Type 2 Diabetes treatment in 2024 include: <ol> <li>Sodium-Glucose Cotransporter 2 (SGLT-2) Inhibitors (e.g., Empagliflozin, Canagliflozin) - These reduce blood glucose by increasing urinary glucose excretion.</li> <li></li> </ol> Glucagon-like Peptide-1 (GLP-1) Receptor Agonists (e.g., Semaglutide, Liraglutide) - These enhance glucose-dependent insulin secretion, delay gastric emptying, and reduce food intake. 3. Glucokinase Activators - These enhance the activity of glucokinase, similar to Dorzagliatin, but with potentially different pharmacokinetic profiles. 4. Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (e.g., Linagliptin) - These prolong the action of incretin hormones, increasing insulin release and decreasing glucagon levels. 5. Glucagon Receptor Antagonists - These reduce hepatic glucose production by blocking glucagon receptors.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests three treatments (Insulin glargine, Metformin, Dorzagliatin) on people with type 2 diabetes to see if they can control nighttime blood sugar levels. These treatments work by either providing insulin, reducing sugar production, or improving natural blood sugar regulation.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP)

Secondary study objectives

Contribution of glycogenolysis (GLY) to EGP

Glucokinase activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 6Eligibility criteria met

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.