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Type 2 Diabetes clinical trials

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NCT ID: NCT06135935 Recruiting - Type 2 Diabetes Clinical Trials

Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream

Start date: November 12, 2023
Phase: N/A
Study type: Interventional

KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.

NCT ID: NCT06131372 Recruiting - Obesity Clinical Trials

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.

NCT ID: NCT06125119 Recruiting - Type 2 Diabetes Clinical Trials

Development of Minimally Invasive Methodology for Diabetyping to Personalise Treatment to Realise Remission and Reversal of Type 2 Diabetes

2DIAREM
Start date: March 18, 2024
Phase:
Study type: Observational

Rationale: Lifestyle changes in diet and exercise can reverse type 2 diabetes (T2D), also referred to as T2D remission. Although combined lifestyle interventions for T2D remission are promising, not all persons react similarly to such 'one-size-fits-all' interventions. Research has shown that as a result of differences in T2D pathophysiology between individuals, different subgroups of T2D can be identified, that differ in which diet is most beneficial in the recovery of pancreatic beta-cell function. TNO and partners work on the development of the Diabetyping Lifestyle Intervention (DLI) for T2D subtypes that tailors the combined lifestyle intervention based on organ dysfunction (liver, muscle and/or pancreatic beta cell function) by using the Oral Glucose Tolerance Test (OGTT). Current diabetyping is invasive, needs to take place in a clinical setting, and therefore is not suited for scaling to application in the large T2D population of more than 1 million people. Therefore, less invasive, scalable alternatives are warranted. Objective: The main objective of the 2DIAREM study is to develop minimally invasive alternatives of diabetyping. Two alternative sampling methods will be evaluated, finger pricks and continuous glucose monitoring (CGM). Data collected through these technologies may be used to predict OGTT indices and diabetypes to guide personalized lifestyle interventions for T2D patients. Furthermore, the investigators aim to develop and evaluate the minimally invasive diabetyping technology with algorithms based on finger prick sampling and multi-day CGM upon a standardized snack or multi-day CGM only under real-world conditions. Study design: The study will be an observational study, lasting 20 days and consisting of three mornings with measurements. Study population: A heterogenous group of people with overweight/(pre)diabetes type 2. The investigators aim for equal distribution among overweight/prediabetes, mild diabetes, and severe diabetes in the study population. Intervention (if applicable): During the 20 days of monitoring participants are asked to undergo one OGTT and consume two times a standardized snack (Snelle Jelle (naturel 65 gram)) after an overnight fast. In between participants are asked to follow their usual lifestyle. Main study parameters/endpoints: Continuously measured subcutaneous glucose, as well as, glucose and insulin, and c-peptide collected via capillary sampling for the development of algorithms predicting the different diabetypes and the underlying indices based on venous blood glucose and insulin. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of this study consists of the application and removal of the continuous glucose monitor device, and the consumption of a sweet beverage (OGTT) and two standardized snacks and undergoing several capillary blood draws. The risks associated with participation can be considered negligible, and are mainly associated with the glucose sensor and the OGTT. The glucose sensor provides a small risk of adverse events including skin irritation, skin infection, and skin colouring. The OGTT poses a small risk of hypo- or hyperglycaemia and can lead to nausea. However, experienced medical professionals are present at the clinic and will closely monitor well-being and health status of the study participants. Benefits include that data collected through the technologies may be used to predict OGTT indices and diabetypes much less invasively and scalable to guide personalized lifestyle interventions for T2D patients.

NCT ID: NCT06120881 Recruiting - Type 2 Diabetes Clinical Trials

Precision Dosing of Metformin in Youth With T2D

PRECISE_T2D
Start date: April 1, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

NCT ID: NCT06118008 Recruiting - Type 2 Diabetes Clinical Trials

A Study of HS-20094 in T2DM Participants

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.

NCT ID: NCT06115265 Recruiting - Obesity Clinical Trials

Ketogenic Diet and Diabetes Demonstration Project

KDDP
Start date: September 5, 2023
Phase: N/A
Study type: Interventional

KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet. The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

NCT ID: NCT06111833 Recruiting - Type 2 Diabetes Clinical Trials

Optimized Diagnosis and Precision Medicine of MODY

Start date: May 22, 2023
Phase:
Study type: Observational

The goal of this observation is to establish a complete registry for the clinical manifestations, environment, genetic, and other related gene variation information of young-onset diabetic patients. Moreover, according to the physiological and pathological mechanisms of different genes, the impact on the clinical characteristics of diabetes, the therapeutic response to drugs, and the impact on complications will be analyzed. The main questions are: 1. The distribution of different types of MODY 2. The phenotypes and clinical characteristics of different types of MODY 3. Response to antidiabetic drugs among different types of MODY Once the participant is enrolled, their questionnaire information (including disease course and development, health history, family history, drug history, etc.), medication, outpatient/inpatient medical history, etc. will be collected and logged in. Blood and urine samples will also be collected for biochemical tests genetic testing, etc. At the same time, the investigators will conduct a continuous follow-up on a regular basis (3 months, 6 months, 12 months, 24 months, and 5 years after the study subject is enrolled). Young-onset type 2 diabetes will be compared to see the difference in clinical presentations and responses to antidiabetic drugs.

NCT ID: NCT06111508 Recruiting - Type 2 Diabetes Clinical Trials

The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.

CGM-DTx
Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).

NCT ID: NCT06109311 Recruiting - Type 2 Diabetes Clinical Trials

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

ACHIEVE-5
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

NCT ID: NCT06108076 Recruiting - Type 2 Diabetes Clinical Trials

Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes

Start date: January 16, 2024
Phase: Early Phase 1
Study type: Interventional

This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.