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Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment.

2014-08-27 03:15:36 | BioPortfolio

Summary

The purpose of this study is to compare the effectiveness of two different kinds of diabetes medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar levels with little or no weight gain in patients with type 2 diabetes who are not well controlled on two or more oral (by mouth) diabetes medications. Both medications are given by injection with a very small needle just below the surface of your skin (called subcutaneous injection). The medication that you inject will be in addition to your oral medications.

Description

Finding a safe and effective method of improving blood glucose (BG) control without weight gain is one of the major goals of diabetes research. Previous research studies have shown that Levemir and Byetta are safe and effective medications in the treatment of type 2 diabetes. Both drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The use of Levemir and Byetta in combination in this study, is investigational, meaning it is not approved by the FDA for this use. However, the FDA has allowed the use of Levemir and Byetta in combination in this study of safety and effectiveness in improving blood sugar levels with little or no weight gain in people with type 2 diabetes.

Levemir is a long acting insulin that is usually taken once a day at bedtime and can last for up to 24 hours. Unlike most insulins that lower blood glucose levels, but cause weight gain, clinical research trials suggest that Levemir may lower blood glucose levels without causing weight gain and may even result in weight loss.

Byetta is not insulin, but improves blood glucose control by mimicking the action of hormones in the gastrointestinal tract called incretins. The incretin hormones trigger the release of insulin from the pancreas and allow insulin to work more effectively in the body. Byetta also delays the movement of food from the stomach into the small intestine. As a result, people taking Byetta may feel "full" faster and longer, so they eat less. The most common side effect with Byetta is mild to moderate nausea, which improves with time in most people. Clinical research trials that have studied the effects of Byetta have shown that, in addition to lowering blood glucose levels, the use of Byetta resulted in weight loss.

There have been no previous studies that have compared Levemir to Byetta in patients who have failed to achieve blood glucose goals with two or three oral diabetes medications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Type 2

Intervention

Insulin-Levemir, Exenatide-Bayetta, Insulin-Levemir and Exenatide-Bayetta, SenseWear Pro3® armband, DexCom CGM

Location

Walter Reed Army Medical Center
Washington
District of Columbia
United States
20306

Status

Recruiting

Source

Walter Reed Army Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:36-0400

Clinical Trials [2792 Associated Clinical Trials listed on BioPortfolio]

Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of i...

Exenatide (Byetta) Versus Pramlintide (Symlin): Role in Post-Prandial Hyperglycemia

The purpose of this study is to determine whether exenatide and pramlintide will improve blood glucose control after meals when compared to insulin alone.

Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes

The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking in...

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate ...

Observational Study to Evaluate the Safety While Using Levemir®

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical pr...

PubMed Articles [2010 Associated PubMed Articles listed on BioPortfolio]

Insulin Secretion Predicts the Response to Therapy with Exenatide Plus Pioglitazone but not to Basal/Bolus Insulin in Poorly Controlled T2DM Patients: Results from the Qatar Study.

The present study aims to identify predictors for response to combination therapy with pioglitazone plus exenatide versus basal/bolus insulin therapy in T2DM patients who are poorly controlled on maxi...

Exenatide exerts cognitive effects by modulating the BDNF-TrkB neurotrophic axis in adult mice.

Modulation of insulin-dependent signaling is emerging as a valuable therapeutic tool to target neurodegeneration. In the brain, the activation of insulin receptors promotes cell growth, neuronal repai...

Exenatide ameliorates hepatic steatosis and attenuates fat mass and FTO gene expression through PI3K signaling pathway in nonalcoholic fatty liver disease.

Non-alcoholic fatty liver disease (NAFLD) is a common disease associated with metabolic syndrome and can lead to life-threatening complications like hepatic carcinoma and cirrhosis. Exenatide, a gluca...

Cardioprotective Mechanisms of Exenatide in Isoprenaline-Induced Mi: Novel Effects on Myocardial Α-Estrogen Receptor Expression and Igf-1/Igf-2 System.

Myocardial infarction (MI) is one of the main causes of morbidity and mortality in diabetic patients. The antidiabetic glucagon-like polypeptide-1 receptor (GLP-IR) agonists, like exenatide, proved to...

The Effects of Exenatide and Metformin on Endothelial Function in Newly Diagnosed Type 2 Diabetes Mellitus Patients: A Case-Control Study.

Exenatide is a new antidiabetic glucagon-like peptide-1 receptor agonist. In addition to its hypoglycemic effect, exenatide may have a potential protective benefit on vascular endothelial function. Th...

Medical and Biotech [MESH] Definitions

A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.

Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)

An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.

Insulin formulation containing substance which delays or retards time period of the absorption of insulin.

A preparation of insulin and zinc chloride in the form of a crystalline suspension. Typically the duration of ultralente insulin activity lasts between 18-30 hours after dosage.

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