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Find 436 clinical trials for diabetes near Pennsylvania. Connect with research centers in your area.
Showing 101-120 of 436 trials
NCT00057304
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
NCT03429543
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c \< 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c \>= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c \>= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
NCT03495284
A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.
NCT05063734
This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).
NCT00017953
The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
NCT03653091
The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.
NCT02932475
Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
NCT03989232
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.
NCT01779375
The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.
NCT03242343
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
NCT04886388
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) compared to standard medical care in patients with type 2 diabetes.
NCT03060577
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).
NCT03829046
Experimental models have linked lipid lowering therapies with systemic inflammation; however, relatively little is known about this network in clinical populations and specifically how it changes with PCSK9 inhibition. The eligible subjects will have 6 visits in 13 to 16 weeks and will have Repatha/placebo 140mg subcutaneous every 4 weeks for 3 times since randomization visit, blood tests will be done in each visit to evaluate the effects of evolocumab upon biocellular markers potentially altered by PCSK9 inhibition in a population of type 2 diabetes patients with microvascular dysfunction. Primary Aims: Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction. Secondary Aims: 1. To define the association between PCSK 9 concentrations and immune-related phenotype. 2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.
NCT04476472
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.
NCT03844789
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.
NCT05013008
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD). FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required. Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney. In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion. The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.
NCT06177691
The purpose of this extension study is to continue to follow the participants who completed the CLVer RCT for up to 3 additional years. The goal for Cohort A is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by C-peptide levels obtained during a mixed meal tolerance test (MMTT). For both Cohorts A and B, the goal is to determine if the high degree of glycemic control achieved during CLVer with HCL can be maintained once the intensive engagement of the study team is discontinued. At the completion of the RCT, study treatments end. Thus, during the extension study, diabetes management is performed as part of usual care and there is no study treatment.
NCT03195140
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth \> 6 years old with type 1 diabetes (T1D).
NCT03428932
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.
NCT05025852
The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.
