AZD5004 for Type 2 Diabetes (SOLSTICE Trial)
Palo Alto (17 mi)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 data supports the idea that AZD5004 for Type 2 Diabetes is an effective drug?The available research does not provide specific data on AZD5004 for Type 2 Diabetes. Instead, it discusses other treatments like insulin glargine and thiazolidinediones, which are used for managing Type 2 Diabetes. These studies focus on the effectiveness of these treatments in controlling blood sugar levels and improving patient outcomes. Without specific data on AZD5004, we cannot compare its effectiveness to these other treatments.5691415
Is the drug AZD5004 a promising treatment for Type 2 Diabetes?The drug AZD5004, also known as ECC5004, is promising for Type 2 Diabetes because it is part of a class of drugs that can help manage blood sugar levels. These drugs are designed to improve insulin secretion or reduce insulin resistance, which are key issues in Type 2 Diabetes. This means AZD5004 could help people with diabetes better control their blood sugar levels.123713
What safety data is available for AZD5004/ECC5004 in treating Type 2 Diabetes?The provided research does not contain specific safety data for AZD5004 or ECC5004. The articles focus on other antidiabetic drugs such as empagliflozin, semaglutide, exenatide, and others, discussing their safety profiles and adverse effects. To find safety data for AZD5004/ECC5004, further research or specific clinical trial results for these compounds would be necessary.48101112
Do I need to stop my current medications for this trial?The trial does not specify if you need to stop your current medications. However, you can continue taking metformin or an SGLT2 inhibitor if you have been on a stable dose for at least one month before the trial.
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.
Treatment Details
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 SiteAtlanta, 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
Exenatide: a novel incretin mimetic agent for treating type 2 diabetes mellitus. [2018]Maintaining glycemic control is the primary goal for preventing macrovascular and microvascular complications associated with type 2 diabetes. Currently available antidiabetic drugs work in different ways to lower blood glucose levels; unfortunately, each of them has its tolerability and safety concerns. Exenatide is the first drug in a new class known as the incretin mimetic agents. It improves glucose control by mimicking the effects of glucagon-like peptide-1, a natural mammalian incretin hormone secreted during food intake. Exenatide was approved by the U.S. Food and Drug Administration for the treatment of type 2 diabetes in conjunction with metformin and/or sulfonylurea. The recommended dosage is 5 mug to 10 mug twice daily subcutaneously before breakfast and dinner. In randomized, placebo-controlled, 30-week clinical studies, exenatide improved glycemic control and promoted weight loss of up to 2.8 kg. The most common adverse effects were nausea (44%), vomiting (13%), diarrhea (13%), and hypoglycemia (5-36%). Hypoglycemia occurred in a dose-dependent fashion. Patients should be closely monitored for hypoglycemia, especially when exenatide is added to sulfonylurea therapy. Overall, exenatide provides a treatment option for patients with type 2 diabetes who fail to obtain glycemic control while on a maximum dose of metformin and/or sulfonylurea therapy. It is also an alternative therapy for those patients who cannot tolerate other antidiabetic drugs.
Closing the gap between clinical research and clinical practice: can outcome studies with thiazolidinediones improve our understanding of type 2 diabetes? [2006]Recent clinical research has provided a wealth of information to support optimal management strategies in type 2 diabetes mellitus (T2DM). In particular, outcome studies appropriately have had an increasingly important impact on clinical decision-making. Additional, new data are required, however, to close the current gaps in clinical knowledge and improve patient outcomes in T2DM. These outcome studies are particularly important in assessing the long-term benefit of newer agents for which data are available for short-term glycaemic control, effects on lipids and some data on non-traditional cardiovascular risk markers, but outcome data for harder end points relevant to the natural history of T2DM, particularly beta-cell function, are lacking. Outcome studies such as ADOPT and DREAM are investigating the impact of thiazolidinediones (TZDs) on beta-cell function and disease progression in T2DM and impaired glucose tolerance, respectively, the results of which are eagerly anticipated. The primary focus of this article is on TZD outcome studies evaluating beta-cell function and disease progression.
Diabetes Care Protocol: effects on patient-important outcomes. A cluster randomized, non-inferiority trial in primary care. [2019]The Diabetes Care Protocol (DCP) combines task delegation, intensification of diabetes treatment and feedback. It reduces cardiovascular risk in Type 2 diabetes (T2DM) patients. This study determines the effects of DCP on patient-important outcomes.
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.
Beyond metformin: safety considerations in the decision-making process for selecting a second medication for type 2 diabetes management: reflections from a diabetes care editors' expert forum. [2022]The trend toward personalized management of diabetes has focused attention on the differences among available pharmacological agents in terms of mechanisms of action, efficacy, and, most important, safety. Clinicians must select from these features to develop individualized therapy regimens. In June 2013, a nine-member Diabetes Care Editors' Expert Forum convened to review safety evidence for six major diabetes drug classes: insulin, sulfonylureas (SUs), thiazolidinediones (TZDs), glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and sodium glucose cotransporter 2 inhibitors. This article, an outgrowth of the forum, summarizes well-delineated and theoretical safety concerns related to these drug classes, as well as the panelists' opinions regarding their best use in patients with type 2 diabetes. All of the options appear to have reasonably wide safety margins when used appropriately. Those about which we know the most-metformin, SUs, insulin, and perhaps now also TZDs-are efficacious in most patients and can be placed into a basic initial algorithm. However, these agents leave some clinical needs unmet. Selecting next steps is a more formidable process involving newer agents that are understood less well and for which there are unresolved questions regarding risk versus benefit in certain populations. Choosing a specific agent is not as important as implementing some form of early intervention and advancing rapidly to some form of combination therapy as needed. When all options are relatively safe given the benefits they confer, therapeutic decision making must rely on a personalized approach, taking into account patients' clinical circumstances, phenotype, pathophysiological defects, preferences, abilities, and costs.
Comparative efficacy and safety of antidiabetic drug regimens added to stable and inadequate metformin and thiazolidinedione therapy in type 2 diabetes. [2022]Determine the efficacy and safety of antidiabetic agents added-on to metformin and a thiazolidinedione (TZD) in patients with inadequately controlled type 2 diabetes (T2D).
Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes. [2022]The aim of this analysis was to establish the safety profile and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) according to pooled data from several clinical trials.
Pharmacological management of type 2 diabetes: what's new in 2017? [2017]Novelties in the management of type 2 diabetes are dominated by the commercialisation of new glucose-lowering agents, which offer alternatives to older antidiabetic medications, and by the publication of several prospective placebo-controlled outcome trials, which demonstrated not only cardiovascular safety but also cardiovascular and renal protection with some new medications. Areas covered: Updates regarding the use of glucose-lowering agents are discussed from a clinical point of view. Some new viewpoints concern older antidiabetic agents such as metformin, sulfonylureas and glitazones whose benefit-risk balance has been revisited, especially in high risk patients. The recent data regarding DPP-4 inhibitors (gliptins) focused on the safety profile of this pharmacological class, including in patients with impaired renal function. The highlight concerns the cardiovascular (and renal) protection by some GLP-1 receptor agonists (liraglutide, semaglutide) and SGLT2 inhibitors (empagliflozin, canagliflozin) in patients with high cardiovascular risk. Finally, efficacy and safety of new combinations and advances in insulin therapy will be briefly discussed. Expert commentary: The recent data from randomized controlled trials, meta-analyses and observational real-life studies should trigger a revision of the algorithm for the treatment of hyperglycemia in type 2 diabetes, especially in patients with high cardiovascular and/or renal risk.
Systematic Review of Efficacy and Safety of Newer Antidiabetic Drugs Approved from 2013 to 2017 in Controlling HbA1c in Diabetes Patients. [2020]Type 2 Diabetes Mellitus (T2DM) is the most common form of diabetes mellitus and accounts for about 95% of all diabetes cases. Many newer oral as well as parenteral antidiabetic drugs have been introduced in to the market in recent years to control hyperglycemic conditions in diabetes patients and many of these drugs produce potential side effects in diabetes patients. Hence, this systematic review was aimed to analyze and compare the efficacy and safety of oral antidiabetic agents in controlling HbA1c in T2DM patients, that were approved by the United States-Food and Drug Administration (US-FDA) from 2013 to 2017. All randomized controlled, double-blind trials published in English during the search period involving the newer antidiabetic agents were selected. In the outcome assessment comparison, semaglutide demonstrated the highest efficacy in lowering HbA1c, with a 1.6% reduction (p < 0.0001) when given at a dose of 1.0 mg. The safety profile of all the agents as compared to placebo or control were similar, with no or slight increase in the occurrence of adverse events (AEs) but no fatal reaction was reported. The most common AEs of all the antidiabetic agents were gastrointestinal in nature, with several cases of hypoglycemic events. However, among all these agents, semaglutide seems to be the most efficacious drug to improve glycemic control in terms of HbA1c. Alogliptin has the least overall frequency of AEs compared to other treatment groups.
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.
Response to insulin glargine 100 U/mL treatment in newly-defined subgroups of type 2 diabetes: Post hoc pooled analysis of insulin-naïve participants from nine randomised clinical trials. [2023]To assess insulin glargine 100 U/mL (IGlar-100) treatment outcomes according to newly-defined subgroups of type 2 diabetes mellitus (T2DM).
Treatment responses to basal insulin glargine 300 U/ml and glargine 100 U/ml in newly defined subphenotypes of type 2 diabetes: A post hoc analysis of the EDITION 3 randomized clinical trial. [2023]To compare responses to basal insulin glargine 300 U/ml (IGlar-300) and 100 U/ml (IGlar-100) in newly defined subphenotypes of type 2 diabetes.