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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT04243200 Completed - Diabetes Clinical Trials

Ambulance 'Hypos Can Strike Twice' Study

Ambu-HS2
Start date: September 14, 2020
Phase:
Study type: Observational

This study will assess the effectiveness the "Hypos can strike twice" intervention on people with diabetes experiencing hypoglycaemia (or "hypo", meaning low blood sugar). The intervention should help prevent recurrence of "hypos", improve patients' future health, reduce calls to ambulance services and thus reduce NHS pressures and costs. Hypoglycaemia affects increasing numbers of people with diabetes. It is a side effect of treatment with insulin or certain tablets, where blood glucose (sugar) falls causing the brain to malfunction. In mild cases this can lead to sweating, drowsiness and confusion; in more severe cases, coma can occur needing medical assistance for recovery, and if prolonged can be fatal. It results in 1% of calls to ambulance services. The "Hypos can strike twice" intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a "Hypos can strike twice" information booklet which they can read when they recover. Universities of Lincoln and Leicester are working with East Midlands Ambulance Service NHS Trust and patient groups on this study. The "Hypos can strike twice" intervention has now been implemented by ambulance services in Leicester, Northamptonshire, Nottinghamshire, Derbyshire and Lincolnshire from October 2018-May 2019. The investigators will analyse data from the ambulance services before, during and after the introduction of the 'Hypos can strike twice' intervention to evaluate the effect of the intervention on repeat ambulance calls and attendances for hypoglycaemia and the costs and consequences of implementing it. The investigators will also interview/survey ambulance staff who provided the intervention and patients who received it, to understand how and why it works (or does not) and how, if it works, it could be scaled up over a larger geographical area. The duration of this study is 1 year.

NCT ID: NCT04240171 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus

Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Research objectives: The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.

NCT ID: NCT04238702 Completed - Clinical trials for Diabetes Mellitus, Type 2

Renohemodynamic Effects of Combined empagliflOzin and LosARtan

RECOLAR
Start date: November 4, 2020
Phase: Phase 4
Study type: Interventional

Worldwide, diabetic kidney disease (DKD) is the most common cause of chronic and end stage kidney disease. In parallel with the ever-increasing rates of obesity and type 2 diabetes (T2D), the incidence of DKD is expected to further increase in the coming years. DKD is a multi-factorial condition, involving pathophysiological factors such as chronic hyperglycemia, obesity, systemic- and glomerular hypertension, dyslipidemia, oxidative stress and pro-inflammatory cytokines. Large-sized prospective randomized clinical trials indicate that intensified glucose and blood pressure control, the latter especially by using agents that interfere with the renin-angiotensin-aldosterone system (RAS), halts the onset and (particularly) the progression of DKD, in both type 1 diabetes mellitus (T1DM) and T2DM patients. However, despite the wide use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), a considerable amount of patients develop DKD, indicating an unmet need for renoprotective therapies. Sodium-glucose linked transporters (SGLT-2) inhibitors are a relatively novel glucose-lowering drug for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in type 2 diabetes. In addition, SGLT-2 inhibitors reduce blood pressure and body weight. At this point in time, the renoprotective mechanisms involved with SGLT-2 inhibition still remain speculative, though a consistent finding is that SGLT-2 inhibitors reduce estimated eGFR after first dosing, which is reversible after treatment cessation. This "dip" indicates a renal hemodynamic phenomenon reminiscent of the RAS blockers and is thought to reflect a reduction in intraglomerular pressure. The potential renoprotective effects and mechanisms of combination therapy of SGLT-2 inhibitors and RAS inhibitors have not been sufficiently detailed in human type 2 diabetes. Therefore, the current study aims to explore the underlying mechanism of the improved renal hemodynamics and mechanistics of mono- and combination therapy with an SGLT-2 inhibitor and a RAS inhibitor on renal physiology in metformin and/or SU-treated T2DM patients.

NCT ID: NCT04237883 Completed - Diabetes Clinical Trials

Primary Care Clinical Excellence Incentive Study

PCCE
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

As part of UCLA Health's commitment to developing a premier integrated health system built on a foundation of physician-led, team-based primary care, the Department of Medicine (DOM) recently implemented a new performance based incentive plan called the Primary Care Clinical Excellence (PCCE) Incentive Plan. This incentive plan was developed to motivate providers to improve health maintenance screening rates. The UCLA Health DOM Quality team is leading the implementation and evaluation of this new incentive plan across our primary care network. In addition, the DOM Quality team has partnered with the UCLA Anderson School of Management to study the most efficacious ways to frame and communicate performance based incentives. Understanding the factors that motivate physicians to deliver the highest quality primary care will provide pivotal insights into the successful implementation of performance based programs nationwide. The investigators believe that physicians who receive communication built on behavioral principles will demonstrate more motivation towards and success at meeting national primary care screening guidelines.

NCT ID: NCT04237493 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan

Start date: February 14, 2017
Phase: Phase 4
Study type: Interventional

Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.

NCT ID: NCT04237129 Completed - Clinical trials for Diabetes Mellitus, Type 1

PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Start date: August 27, 2019
Phase: Phase 1
Study type: Interventional

Primary objective: To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects Secondary objectives: To compare the PK and PD parameters of the three insulin aspart preparations To evaluate the single dose safety and local tolerability of the three insulin aspart preparations

NCT ID: NCT04236895 Completed - Clinical trials for Diabetes Mellitus, Type 1

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

Start date: July 10, 2018
Phase: Phase 1
Study type: Interventional

Primary objectives: To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins. max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes Secondary objectives: To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP) To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

NCT ID: NCT04236206 Completed - Clinical trials for Diabetes Mellitus, Type 2

Short Message Service for Type 2 Diabetes

SMS4T2D
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Diabetes is a chronic disease where type 1 diabetes (T1D) is due to autoimmune ẞ-cell destruction, usually leading to absolute insulin deficiency, type 2 diabetes (T2D) is due to a progressive loss of ẞ-cell insulin secretion frequently on the background of insulin resistance. A third type-Gestational diabetes mellitus (GDM)-is diagnosed in the second or third trimester of pregnancy and was not clearly overt diabetes prior to gestation (American Diabetes Association. Lifestyle management can enhance diabetes care and it includes diabetes self-management education and support (DSMES), medical nutrition therapy, physical activity, smoking cessation counselling, and psychosocial care. However, health systems cannot control all the factors that influence a person's overall health, as physicians are unable to check regularly what their patients eat or whether they properly adhere to their medications. Pharmacists involved in DSMES can help patients achieve therapeutic and lifestyle goals. This active participation requires that the pharmacist's practice extend beyond the traditional role. Patients and care providers should work together to optimize lifestyle aspects through the entire care process. Telemedicine "healing at a distance" signifies the use of information and communication technology to improve patient outcomes by increasing access to care and medical information. Using mobile and wireless technologies to achieve health objectives (mHealth) can universally transform health services' delivery. Mobile phones can easily reach population since they have exceeded other communication technologies in Low and middle-Income countries (LMICs). The results of the present study will help the policy-makers in the MOHP to understand the importance of creating healthcare systems that meet the needs of patients and providers and develop DSMES strategy with the help of pharmacist educator and using innovative mobile phone technology.

NCT ID: NCT04235959 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

Start date: October 21, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. The study will last about six or eight months for each participant.

NCT ID: NCT04235829 Completed - Hypertension Clinical Trials

Does Early Weight Loss Following Laparoscopic Sleeve Gastrectomy Affect Long-term Outcomes

Start date: April 1, 2012
Phase:
Study type: Observational [Patient Registry]

A study to explore the relationship between early weight loss in the 4 weeks following laparoscopic sleeve gastrectomy and outcomes, in terms of weight loss and comorbidity improvement, 7 years following the surgery.