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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study 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 belowSelect...
My HbA1C is 9% or lower, and I'm on a diet, exercise plan, metformin, or SU.
Select...
My HbA1C is 9% or lower and I'm on specific diabetes medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,364 Previous Clinical Trials
4,315,235 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,591 Previous Clinical Trials
2,281,565 Total Patients Enrolled
University of VirginiaLead Sponsor
756 Previous Clinical Trials
1,245,206 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently taking any TZD medications.You are pregnant, breastfeeding, or have other health conditions that prevent you from taking part in the study.I am on insulin therapy.My HbA1C is 9% or lower, and I'm on a diet, exercise plan, metformin, or SU.I am taking long-acting GLP-1 analogues.Your body mass index (BMI) is between 25 and 40.My HbA1C is 9% or lower and I'm on specific diabetes medications.I have a stomach or upper GI disorder, a serious chronic illness, anemia, or symptoms of an unknown illness.You have a history of drinking too much alcohol or using drugs.I am not taking medications that can affect my blood sugar levels.I do not have unstable diabetic eye issues, kidney problems, or major blood vessel diseases.I am taking medication for diabetes that includes SGLT2 inhibitors.I am not taking medications that affect stomach or bowel movements.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin Glargine
- Group 2: Dorzagliatin
- Group 3: Metformin
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dorzagliatin been cleared by the FDA?
"There is both clinical evidence and extensive data supporting the safety of Dorzagliatin, thus we have rated it a 3."
Answered by AI
What is the scale of this clinical trial in terms of participants?
"The information available on clinicaltrials.gov verifies that this study is still in the process of recruiting patients. The trial was first advertised on March 7th, 2022 and was updated as recently as July 19th, 2022. They are currently looking for 100 patients that will participate at 2 locations."
Answered by AI
What are the conditions that Dorzagliatin is commonly used to improve?
"Though dorzagliatin is most often used to treat type 1 diabetes mellitus, it has also been found to help patients that suffer from hyperglycemia, diabetic ketoacidosis, and diabetes mellitus."
Answered by AI
Will this clinical trial exclude patients that are over 65 years old?
"The age limit for potential patients in this study is 80 years old. Anyone younger than 25 will not be able to participate."
Answered by AI
Are there any similar trials to the Dorzagliatin study?
"Presently, there are a total of 194 active clinical trials researching Dorzagliatin. Out of these ongoing investigations, 51 are currently in Phase 3. Most of the research teams are based in Rockville, Maryland; however, there are 2172 total locations running studies for Dorzagliatin."
Answered by AI
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