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?
Research shows that insulin glargine (Lantus) is effective and safe for people with type 2 diabetes, especially when combined with other diabetes medications. Studies found it helps control blood sugar levels in patients who were not well-managed on other treatments.
12345Is the treatment generally safe for humans?
Research shows that insulin glargine (including Basaglar and Lantus) and dorzagliatin have been studied for safety in people with type 2 diabetes. These studies generally indicate that these medications are safe for human use, although some users may experience adverse events.
12678What 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.
89101112Eligibility 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.
+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
Participant Groups
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
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 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).
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.
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]To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with insulin glargine (Lantus; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin-naive Chinese patients with type 2 diabetes (T2D).
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).
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.
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.
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.
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.