Advertisement

Topics

A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics

2014-08-27 03:12:48 | BioPortfolio

Summary

The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.

Description

This is a multi-center study that will enroll approximately 36 subjects. The study consists of three periods of two days of dosing each. The study will evaluate 5 potential dose regimens. Each subject will receive a randomized sequence of treatments over three periods, with placebo treatment in one period and two different active dose regimens in the other two periods. There will be 5 to 12 days of outpatient washout between treatment periods. Subjects will continue their current treatment on metformin throughout the study. Subjects will monitor blood glucose levels daily via glucometer during oupatient washout periods. A follow-up visit will occur between 5 and 10 days after the last period of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Diabetes Mellitus, Type 2

Intervention

Placebo, GSK256073, GSK256073, GSK256073, GSK256073

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

Clinical Trials [4832 Associated Clinical Trials listed on BioPortfolio]

Study to Test GSK256073 in Patients With Dyslipidemia

This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the eff...

Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.

MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

ECG Changes Including QT Dispersion and Corrected QT Prolongation in Children and Adolescents With Type 1 Diabetes

Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes...

A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to investigate the effects of blocking IL-1 signaling with AMG 108 in type 2 diabetes mellitus patients on glycemic control, as measured by change in HbA1c fro...

PubMed Articles [10342 Associated PubMed Articles listed on BioPortfolio]

Efficacy of metformin on glycemic control and weight in drug-naive type 2 diabetes mellitus patients: A systematic review and meta-analysis of placebo-controlled randomized trials.

Metformin is recommended as the first-line treatment of type 2 diabetes mellitus. Despite its common use, few studies have been conducted to precisely measure the efficacy of metformin versus placebo ...

Diabetes-related cognitive dysfunction:Hyperglycemia in the early stage may be a key?

Type 2 diabetes mellitus has been an established risk factor for cognitive decline, which is recently recognized as a new type of diabetes-related complication. Although wide-range of cognitive domain...

Diabetes remission and relapse after metabolic surgery.

Obesity and type 2 diabetes mellitus are prevalent all over the world. Obese patients with more visceral fat are more likely to suffer from type 2 diabetes mellitus, hypertension, dyslipidemia and obs...

Efficacy and Safety of Alirocumab in Individuals with Diabetes Mellitus: Pooled Analyses from Five Placebo-Controlled Phase 3 Studies.

Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies.

The Variation of Disulfides in the Progression of Type 2 Diabetes Mellitus.

The purpose of this study was to examine thiol-disulfide balance in patients with type 2 diabetes mellitus.

Medical and Biotech [MESH] Definitions

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.

A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).

A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

More From BioPortfolio on "A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Diabetes
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...


Searches Linking to this Trial