Diabetes Medications for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Insulin, SGLT2 inhibitors
Disqualifiers: Unstable diabetic retinopathy, macrovascular disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on insulin therapy, SGLT2 inhibitors, long-acting GLP-1 analogues, or certain other medications that affect glucose metabolism. It's best to discuss your current medications with the study team to see if they are allowed.
What data supports the effectiveness of the drug Dorzagliatin, HMS5552, Insulin Glargine, Lantus, Basaglar, Rezvoglar, Metformin, Glucophage, Fortamet, Glumetza, Riomet for treating type 2 diabetes?
Is the treatment generally safe for humans?
What makes the drug dorzagliatin unique for treating type 2 diabetes?
Dorzagliatin is unique because it is a glucokinase activator that helps control blood sugar by activating enzymes in the pancreas and liver in a way that depends on glucose levels. This mechanism is different from other diabetes medications, which often target insulin directly or work through other pathways.89101112
Research Team
Eligibility Criteria
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.Inclusion Criteria
My HbA1C is 9% or lower, and I'm on a diet, exercise plan, metformin, or SU.
Your body mass index (BMI) is between 25 and 40.
My HbA1C is 9% or lower and I'm on specific diabetes medications.
Exclusion 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.
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomly assigned to one of three treatment groups (Insulin, Metformin, or Dorzagliatin) for 8 weeks to assess the effects on nighttime blood sugar levels.
8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Dorzagliatin (Anti-diabetic agent)
- Insulin Glargine (Insulin)
- Metformin (Anti-diabetic agent)
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: DorzagliatinExperimental Treatment1 Intervention
Group II: Insulin GlargineActive Control1 Intervention
Group III: MetforminActive Control1 Intervention
Dorzagliatin is already approved in China for the following indications:
Approved in China as Dorzagliatin for:
- Type 2 diabetes mellitus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rita BasuCharlottesville, VA
Rita BasuBirmingham, AL
Loading ...
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Trials
1677
Patients Recruited
2,458,000+
University of Virginia
Lead Sponsor
Trials
802
Patients Recruited
1,342,000+
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Trials
2513
Patients Recruited
4,366,000+
Findings from Research
In a study involving 1,291 patients with type 1 and type 2 diabetes, LY2963016 insulin glargine (LY IGlar) showed similar immunogenicity profiles to Lantus® insulin glargine (IGlar), with low levels of anti-insulin glargine antibodies observed in both groups.
There were no significant differences in clinical outcomes or safety between LY IGlar and IGlar, indicating that both treatments are equally effective and safe for managing diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus.Ilag, LL., Deeg, MA., Costigan, T., et al.[2018]
In a 24-week phase III study involving 756 patients with type 2 diabetes, LY2963016 insulin glargine (LY IGlar) demonstrated non-inferiority to the reference product Lantus(®) (IGlar) in reducing HbA1c levels, indicating it is equally effective for glucose control.
Both LY IGlar and IGlar had similar safety profiles, with no significant differences in adverse events, weight change, or hypoglycemia, suggesting that LY IGlar is a safe alternative to IGlar for patients with type 2 diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study).Rosenstock, J., Hollander, P., Bhargava, A., et al.[2022]
In a pilot study involving 52 patients with Type 2 diabetes poorly controlled on premixed insulin, switching to insulin glargine combined with oral antidiabetic drugs (OADs) significantly improved glycaemic control, as evidenced by a notable decrease in HbA1c levels in both treatment groups (A and B).
The study found no significant differences in hypoglycaemia rates between the treatment groups, indicating that insulin glargine plus OADs is a safe alternative to premixed insulin therapy, with high patient satisfaction leading to a majority opting to continue their assigned treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot study.Schiel, R., Müller, UA.[2022]
In a pilot study of 52 patients with Type 2 diabetes, switching from premixed insulin to insulin glargine combined with oral antidiabetic drugs (OADs) led to significant reductions in HbA1c levels, indicating improved glycaemic control.
The study found no significant differences in hypoglycaemia rates between the treatment groups, suggesting that insulin glargine plus OADs is a safe alternative to premixed insulin for patients with inadequate glycaemic control.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with Type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study.Schiel, R., Müller, UA.[2022]
In a phase III trial involving 536 insulin-naive Chinese patients with type 2 diabetes, LY2963016 insulin glargine (LY IGlar) demonstrated non-inferiority to Lantus (IGlar) in reducing HbA1c levels over 24 weeks, with both treatments achieving similar significant reductions.
Both LY IGlar and IGlar had comparable safety profiles, with no significant differences in adverse events, hypoglycemia, or weight gain, indicating that LY IGlar is a safe and effective alternative to IGlar for managing blood sugar levels.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial.Feng, W., Chen, W., Jiang, S., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study.Pollom, RK., Costigan, T., Lacaya, LB., et al.[2020]
The follow-on insulin glargine (Basaglar) has seen increased uptake among users, rising from 8.2% in 2017 to 24.8% in 2020, while the use of the originator insulin (Lantus) has decreased, indicating a shift in prescribing patterns.
Users of the follow-on insulin had poorer baseline health profiles and experienced higher rates of adverse events compared to users of the originator insulin, suggesting that further research is needed to understand the implications of these differences.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the United States.Rai, A., Nam, YH., Mendelsohn, AB., et al.[2023]
Dorzagliatin significantly reduced glycated hemoglobin levels by 0.66% and fasting plasma glucose by 6.77 mg/dL in patients with type 2 diabetes mellitus, based on a meta-analysis of 3 studies involving 1333 patients.
The treatment was well tolerated, showing a good safety profile for liver and kidney function, although there was a slightly higher risk of adverse events compared to placebo.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Phase II/III Trials.Lin, F., He, R., Ling, B., et al.[2023]
In drug-naïve patients with type 2 diabetes, treatment with dorzagliatin resulted in a 65.2% probability of achieving drug-free diabetes remission after 52 weeks, indicating its effectiveness in maintaining stable glycaemic control.
Key factors contributing to this remission included significant improvements in insulin secretion and glucose homeostasis, as evidenced by increased time in range (TIR) from 60% to over 80%, highlighting dorzagliatin's positive impact on β-cell function.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Diabetes remission in drug-naïve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study.Zeng, J., Gan, S., Mi, N., et al.[2023]
In a study of veterans with type 2 diabetes, combining GLP-1 receptor agonists and SGLT2 inhibitors led to a significant 1% reduction in HbA1c levels after 12 weeks, indicating improved glycemic control.
The combination therapy also resulted in a notable weight loss of about 5 kg (5%) and a significant decrease in systolic blood pressure over the study period, demonstrating additional health benefits beyond blood sugar management.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and Efficacy of GLP-1 Receptor Agonists and SGLT2 Inhibitors Among Veterans With Type 2 Diabetes.McCulley, L., Hurren, KM.[2023]
Dorzagliatin is an oral glucokinase activator that improves blood sugar control in type 2 diabetes by activating glucokinase in the pancreas and liver, and it works in a glucose-dependent way.
In September 2022, dorzagliatin was approved in China for use as a standalone treatment and as an add-on to metformin for adults with type 2 diabetes, marking a significant milestone in its development.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Dorzagliatin: First Approval.Syed, YY.[2022]
In a phase 1 trial involving 15 patients with type 2 diabetes and obesity, the combination of dorzagliatin and sitagliptin was found to be safe and well-tolerated, with no increase in adverse events compared to sitagliptin alone.
The study demonstrated no clinically meaningful pharmacokinetic interactions between dorzagliatin and sitagliptin, suggesting that their co-administration could improve glycemic control in diabetes management.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase I open-label clinical trial to study drug-drug interactions of Dorzagliatin and Sitagliptin in patients with type 2 diabetes and obesity.Chen, L., Zhang, J., Sun, Y., et al.[2023]
References
Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. [2018]
Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). [2022]
Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with type 2 diabetes previously on long-term conventional insulin therapy: the Switch pilot study. [2022]
Efficacy and treatment satisfaction of once-daily insulin glargine plus one or two oral antidiabetic agents versus continuing premixed human insulin in patients with Type 2 diabetes previously on long-term conventional insulin therapy: the SWITCH Pilot Study. [2022]
Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial. [2022]
Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. [2020]
Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the United States. [2023]
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Phase II/III Trials. [2023]
Diabetes remission in drug-naïve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study. [2023]
Safety and Efficacy of GLP-1 Receptor Agonists and SGLT2 Inhibitors Among Veterans With Type 2 Diabetes. [2023]
Dorzagliatin: First Approval. [2022]
A phase I open-label clinical trial to study drug-drug interactions of Dorzagliatin and Sitagliptin in patients with type 2 diabetes and obesity. [2023]