AZD5004 for Type 2 Diabetes (SOLSTICE Trial)
Recruiting in Palo Alto (17 mi)
+100 other locations
Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AstraZeneca
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.
What makes the drug AZD5004 unique for treating type 2 diabetes?
AZD5004, also known as ECC5004, is unique because it may offer a novel approach to managing type 2 diabetes, potentially involving a different mechanism of action or administration compared to existing treatments like metformin, sulfonylureas, and thiazolidinediones. However, specific details about its uniqueness are not provided in the available research.
12345Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it allows participants who are on a stable dose of metformin or an SGLT2 inhibitor. It seems you can continue these medications if they are stable.
Eligibility Criteria
This trial is for adults with type 2 diabetes who have not achieved adequate blood sugar control. Participants should be able to take oral medication and commit to the study for 26 weeks. Specific medical conditions or treatments that could interfere with the study are reasons for exclusion.Inclusion Criteria
I am 18 years old or older.
Exclusion Criteria
I have had pancreatitis before.
I have had or plan to have weight loss surgery or a device fitted.
I have type 1 diabetes or a history of severe diabetes complications.
I have had serious eye problems due to diabetes that needed immediate treatment.
Participant Groups
The trial tests a new once-daily pill, AZD5004, against a placebo (a dummy pill) and Semaglutide, an existing diabetes medication. The goal is to see if AZD5004 is effective in controlling blood sugar levels over a period of 26 weeks.
8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 6Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group II: Arm 5Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group III: Arm 4Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group IV: Arm 3Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group V: Arm 2Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VI: Arm 1Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VII: Arm 7Active Control1 Intervention
Participants will receive once daily dose of Semaglutide as active comparator
Group VIII: Arm 8Placebo Group1 Intervention
Participants will receive matching placebo for each AZD5004 arm
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Research SiteMobile, AL
Research SiteVestavia Hills, AL
Research SiteOcoee, FL
Research SiteSavannah, GA
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
References
In vivo prevention of hyperglycemia also prevents glucotoxic effects on PDX-1 and insulin gene expression. [2022]Chronic exposure of pancreatic islet beta-cell lines to supraphysiologic glucose concentrations causes defects in insulin gene expression and insulin secretion. To determine whether these in vitro phenomena have pathophysiologic relevance in vivo, we studied the Zucker diabetic fatty (ZDF) rat, an animal model of type 2 diabetes. The ZDF animals had relatively higher levels of glycemia and islet insulin mRNA at 6 weeks of age than age-matched Zucker lean control (ZLC) rats. As glycemia increased in 12- and 16-week-old ZDF rats, we observed decrements in glucose-induced insulin secretion during static incubations of pancreatic islets and in insulin mRNA levels, PDX-1 mRNA levels, and PDX-1 protein binding to the insulin promoter compared with age-matched ZLC rats and 6-week-old ZDF rats. To determine whether normalization of blood glucose levels would prevent these defects, ZDF rats were treated with troglitazone beginning at 6 weeks of age. Troglitazone prevented ZDF rats from becoming hyperglycemic and preserved glucose-induced insulin responses. Furthermore, troglitazone-treated ZDF animals had greater levels of insulin and PDX-1 mRNAs compared with untreated ZDF animals of the same ages at 12 and 16 weeks. Our results demonstrate that chronic and progressive hyperglycemia resulting from type 2 diabetes in ZDF rats is associated with loss of insulin and PDX-1 mRNAs and loss of glucose-stimulated insulin secretion. Prevention of hyperglycemia prevented the associated defects in insulin and PDX-1 gene expression and improved insulin secretion. These findings provide the first in vivo evidence that prevention of progressive hyperglycemia in a model of type 2 diabetes preserves insulin and PDX-1 gene expression.
Novel sulfonylurea and non-sulfonylurea drugs to promote the secretion of insulin. [2019]The onset of type 2 diabetes is characterized by two determining factors: the insufficient ability to secrete insulin and/or the resistance to its biological action. Although in a very small proportion of individuals, one of those two metabolic abnormalities is the leading cause of diabetes, in most subjects, the coexistence of both appears to be necessary for the clinical manifestation of diabetes. Current biomedical research continues to clarify the relative contributions of these defects to the pathogenesis of type 2 diabetes, and novel pharmacological agents are specifically designed to correct either the impaired insulin secretory activity or the resistance to the action of insulin. The aim of this article is to provide a critical review of new sulfonylurea and non-sulfonylurea drugs that have been recently introduced for the treatment of diabetes, as well as drugs that are still under investigation and are likely to be made available in the near future.
The metabolic effects of troglitazone in patients with diabetes and end-stage renal disease. [2018]Thiazolidinediones (TZD) are effective agents for the treatment of hyperglycemia, and appear ideal in diabetic patients with progressive or end-stage renal disease because of its predominant hepatic clearance. Troglitazone, the first available TZD for clinical use, was withdrawn due to safety concerns; however, studies completed with this agent can provide a better understanding of the class effect of TZDs. This study was an open-label, controlled clinical trial examining the safety and efficacy of troglitazone in type 2 diabetic patients with end-stage renal disease (ESRD). Twelve subjects were randomized to parallel study groups and treated for 6 mo with or without troglita-zone at a maximum dose of 600 mg/d in addition to continuing their previous diabetes medications (insulin or sulfonylurea). The results showed no significant differences in glycemic control with or without troglit-azone treatment for 6 mo. However, there was a significant reduction in insulin dosage with troglitazone treatment (22.9 +/- 7.3 units/d) than without troglita-zone treatment (54 +/- 12.9 units/d) (p
A review of the efficacy and safety of oral antidiabetic drugs. [2022]Additional oral antidiabetic agents to metformin, sulfonylureas (SU) and thiazolidinediones (TZD) are approved for the treatment of type 2 diabetes.
Zucker Diabetic-Sprague Dawley (ZDSD) rat: Type 2 diabetes translational research model. [2022]What is the topic of this review? The Zucker Diabetic-Sprague Dawley (ZDSD) rat is in the early adoption phase of use by researchers in the fields of diabetes, including prediabetes, obesity and metabolic syndrome. It is essential that physiology researchers choose preclinical models that model human type 2 diabetes appropriately and are aware of the limitations on experimental design. What advances does it highlight? Our review of the scientific literature finds that although sex, age and diets contribute to variability, the ZDSD phenotype and disease progression model the characteristics of humans who have prediabetes and diabetes, including co-morbidities.