Diabetes Medications for Type 2 Diabetes
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Alabama at Birmingham
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.
Is the drug Dorzagliatin, Insulin Glargine, Metformin a promising treatment for type 2 diabetes?Yes, Dorzagliatin, when used with Insulin Glargine and Metformin, shows promise for treating type 2 diabetes. Dorzagliatin helps control blood sugar levels and has been approved in China for use with Metformin. It has been shown to improve blood sugar control and is well-tolerated in patients.678911
What safety data exists for diabetes medications like Dorzagliatin and Insulin Glargine?Safety data for Insulin Glargine, including Basaglar and Lantus, shows similar efficacy and safety profiles in patients with type 2 diabetes, regardless of age. Studies indicate that follow-on Insulin Glargine (Basaglar) has been increasingly used since 2016, with users having a poorer baseline health profile and higher adverse event rates compared to originator products. Dorzagliatin, a glucokinase agonist, has been evaluated for safety in phase II/III trials, showing efficacy and safety in treating type 2 diabetes.3451011
What data supports the idea that Diabetes Medications for Type 2 Diabetes is an effective treatment?The available research shows that insulin glargine, a type of diabetes medication, is effective for treating Type 2 Diabetes. Studies have found that insulin glargine, whether as the original product Lantus or the follow-on drug Basaglar, helps manage blood sugar levels effectively. For instance, the ELEMENT 2 study demonstrated that insulin glargine is as effective and safe as Lantus when used with other diabetes medications. Additionally, the Switch pilot study found that adding insulin glargine to other diabetes drugs improved blood sugar control in patients who were not well-managed on other insulin therapies. This suggests that insulin glargine is a reliable option for managing Type 2 Diabetes.123410
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you must stop your current medications. However, you cannot participate if you are on insulin therapy, SGLT2 inhibitors, long-acting GLP-1 analogues, TZDs, or medications affecting glucose metabolism and GI motility. If you are on metformin or sulphonylureas, you may be eligible.
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.
My HbA1C is 9% or lower and I'm on specific diabetes medications.
Exclusion Criteria
I am on insulin therapy.
I am taking long-acting GLP-1 analogues.
I do not have unstable diabetic eye issues, kidney problems, or major blood vessel diseases.
I am not taking medications that affect stomach or bowel movements.
Treatment Details
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.
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 BirminghamLead Sponsor
University of VirginiaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
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]Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy.
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]Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy.
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]To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus(®)) insulin glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D).
Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus. [2018]To compare the immunogenicity profiles and the potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM).
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]Label="INTRODUCTION" NlmCategory="BACKGROUND">To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D).
Dorzagliatin: First Approval. [2022]Dorzagliatin (HuaTangNing) is an oral glucokinase activator that is being developed by Hua Medicine for the treatment of type 2 diabetes mellitus (T2DM), type 1 diabetes mellitus (T1DM) and diabetic kidney disease (DKD). Dorzagliatin improves glycaemic control by activating pancreatic and hepatic glucokinase in a glucose-dependent manner. In September 2022, dorzagliatin (with diet control and exercise) as monotherapy and as an add-on to metformin (when glycaemic control is inadequate with metformin alone) was approved in China for improving glycaemic control in adult patients with T2DM. This article summarizes the milestones in the development of dorzagliatin leading to this first approval.
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]This is a phase 1, open-label, single-sequence, multiple-dose, single-center trial conducted in the US (NCT03790839), to evaluate the clinical pharmacokinetics, safety and pharmacodynamics of dorzagliatin co-administered with sitagliptin in patients with T2D and obesity. The trial has completed. 15 patients with T2D and obesity were recruited and treated with sitagliptin 100 mg QD on Day 1-5, followed by a combination of sitagliptin 100 mg QD with dorzagliatin 75 mg BID at second stage on Day 6-10 and the third stage of dorzagliatin 75 mg BID alone on Day 11-15. Primary outcomes include pharmacokinetic geometric mean ratio (GMR), safety and tolerability. Secondary outcomes include the incremental area under the curve for 4 hours post oral glucose tolerance test (iAUC) of pharmacodynamic biomarkers and glucose sensitivity. GMR for AUC0-24h and Cmax were 92.63 (90% CI, 85.61, 100.22) and 98.14 (90% CI, 83.73, 115.03) in combination/sitagliptin, and 100.34 (90% CI, 96.08, 104.79) and 102.34 (90% CI, 86.92, 120.50) in combination/dorzagliatin, respectively. Combination treatment did not increase the adverse events and well-tolerated in T2D patients. Lack of clinically meaningful pharmacokinetic interactions between dorzagliatin and sitagliptin, and an improvement of glycemic control under combination potentially support their co-administration for diabetes management.
Safety and Efficacy of GLP-1 Receptor Agonists and SGLT2 Inhibitors Among Veterans With Type 2 Diabetes. [2023]Choosing the best medication regimen for a patient with type 2 diabetes mellitus (T2DM) depends on glycemic control, adherence, adverse effect profile, and comorbid conditions. Two new medication classes, glucagon-like peptide 1 receptor agonists (GLP-1 RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i), have demonstrated cardiovascular and renal protective properties, creating a new way to care for patients with T2DM.
Diabetes remission in drug-naïve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study. [2023]To investigate the post-treatment effect of dorzagliatin in drug-naïve patients with type 2 diabetes (T2D) regarding the achievement of stable glycaemic control and drug-free diabetes remission.
Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the United States. [2023]BACKGROUND: The first follow-on drug (Basaglar) of the originator insulin glargine (Lantus), a long-acting insulin for treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM), was approved in 2015 in the United States. Information on the uptake, user characteristics, and outcomes of follow-on insulin remains sparse. OBJECTIVE: To describe the utilization, user characteristics, and health outcomes of the follow-on insulin glargine and insulin glargine originators in a large, distributed network of primarily commercially insured patients in the United States. METHODS: We used health care claims data in the US Food and Drug Administration's Sentinel common data model format across 5 research partners in the Biologics & Biosimilars Collective Intelligence Consortium distributed research network. Sentinel analytic tools were used to identify adult users of insulin glargine between January 1, 2011, and February 28, 2021, and describe patient demographics, baseline clinical characteristics, and adverse health events among users of the originators and the follow-on drug, stratified by diabetes type. RESULTS: We identified 508,438 users of originator drugs and 63,199 users of the follow-on drug. The proportions of the follow-on drug users among total insulin glargine users were 9.1% (n = 7,070) for T1DM and 11.4% (n=56,129) for T2DM. Follow-on use rose from 8.2% in 2017 to 24.8% in 2020, accompanied by a steady decrease in the use of originator drugs. Demographics of the users of the originators and follow-on drug were similar among the T1DM and T2DM groups. Overall, follow-on users had poorer baseline health profile and higher proportions of episodes with adverse events in the follow-up. CONCLUSIONS: We found evidence of increased uptake of the follow-on drug relative to the originator products in the post-2016 period. The differences in the base-line clinical characteristics between users of the originator products and the follow-on drug and their relationship with health outcomes merit further research. DISCLOSURES: Sengwee Toh consults for Pfizer, Inc., and TriNetX, LLC. This study was funded by the BBCIC.
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Phase II/III Trials. [2023]Dorzagliatin is a glucokinase agonist with effects on type 2 diabetes mellitus (T2DM). This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.