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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00494559 Completed - Diabetes Mellitus Clinical Trials

The Effect of Pioglitazone on Neointima Volume and Inflammatory Markers

Start date: July 2007
Phase: Phase 4
Study type: Interventional

People with diabetes mellitus are more prone to coronary heart disease, stroke, and peripheral vascular disease, and diabetes mellitus has been regarded as an independent risk factor for the progression of coronary artery disease. Several studies have been reported that diabetes increased the risk of cardiovascular mortality in both men and women. With the introduction of drug-eluting stents (DESs), the angiographic rates of restenosis at later months have reduced dramatically in several studies. However, even with DESs, diabetic patients showed increased rates of restenosis and late loss index compared with nondiabetic patients. Diabetes has been considered to be a predictor of poor prognosis after percutaneous coronary intervention with drug-eluting stents. Long-term clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with drug-metal stents (DESs) have been demonstrated to be worse in diabetic patients compared with nondiabetic patients. In the era of DESs, no study has demonstrated the clinical and angiographic outcomes in diabetic patients after zotarolimus-eluting stent implantation by using intravascular ultrasound (IVUS). Pioglitazone is used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect on blood glucose levels and lipid profiles. The effect of pioglitazone on neointima volume and inflammatory markers has not been compared in prospective manner after zotarolimus-eluting stent implantation. The purpose of this prospective, randomized, single blinded trial is to compare the effect of pioglitazone on inflammatory markers and neointima volume by using IVUS in diabetic patients.

NCT ID: NCT00494312 Completed - Diabetes Mellitus Clinical Trials

Safety Study of Pioglitazone Compared To Glyburide on Liver Function

Start date: October 2000
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD), versus glyburide taken with metformin and insulin.

NCT ID: NCT00494013 Completed - Clinical trials for Diabetes Mellitus Type 2

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

IOOY
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

NCT ID: NCT00493935 Completed - Clinical trials for Diabetes Mellitus, Type I

Effect of the Fat Content of the Bedtime Snack on Overnight Hypoglycemia

Start date: March 2006
Phase: N/A
Study type: Observational

Low blood sugar at night (called nocturnal hypoglycemia), can often happen without symptoms and can last for a long time. Doctors often suggest that patients take a bedtime snack to try to prevent low blood sugar at night from happening, but it is not known what type of snack is best to take. We are conducting a study to evaluate how two different types of snacks affect how often the blood sugar is too low overnight. One snack will be a primarily carbohydrate snack and the other will be a carbohydrate snack with fat. The snacks will be provided by the study. As part of the study, a continuous glucose sensor (the Freestyle Navigator) will be worn overnight. The Freestyle Navigator was developed by Abbott Diabetes Care. This sensor uses a glucose oxidase based electrochemical sensor, and is designed to measure blood glucose levels in a range of 20-500 mg/dl. The sensor is inserted subcutaneously and measures interstitial glucose. In human studies the interstitial glucose levels generally lag behind the blood glucose by 3 to13 minutes.(27, 28) The Freestyle Navigator, provides a glucose reading every 60 seconds (or 1440 readings a day). Each sensor is designed to provide readings for up to 120 hours. It has alarms for hypoglycemia and hyperglycemia and for projected high and low glucose values. The alarm set points can be adjusted by the user. The Navigator also has a trend arrow indicating the glucose rate of change (>-2 mg/dL/min, -2 to -1 mg/dL/min, -1 to 1 mg/dL/min, 1 to 2 mg/dl/min, and >2 mg/dl/min). Subjects can enter events, such as when they took insulin, ate, or exercised. The sensor requires calibration values to be entered 3 times during the first day of wear, and then 2 additional times during the 5-day wear period. The values are entered directly into the Navigator which has a Freestyle home glucose meter built into the unit. The Navigator has not yet been approved by the FDA. The Navigator currently under review by the FDA will limit sensor wear to 3 days. This study is being done to see if there is a difference in low blood sugar overnight after having a bedtime snack made up of carbohydrate compared to a carbohydrate snack with more fat.

NCT ID: NCT00493727 Completed - Diabetes Clinical Trials

Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria

Start date: September 2006
Phase: N/A
Study type: Interventional

The study will look at the effect of 30 days of treatment of 15 diabetics with proteinuria with N-acetylcysteine ( Mucomyst ) at a dose of 1 gm twice a day by mouth. The primary outcome that will be measured is change in the oxidant stress as measurable by changes in the serum level of isoprostane, Glutathione peroxidase, aconitase and Total oxidant stress. Secondary outcomes measured will be changes in proteinuria and kidney function as measured by spot urine pr/cr and estimated GFR by MDRD formula.

NCT ID: NCT00491725 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Start date: September 2005
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

NCT ID: NCT00491543 Completed - Clinical trials for Coronary Artery Disease

Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease

Start date: June 2007
Phase: Phase 2
Study type: Interventional

ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics." ALT-2074 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2 genotype have poor cardiovascular clinical outcomes. The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype

NCT ID: NCT00491023 Completed - Diabetes Clinical Trials

Examining Macrophage Influx and Vascularization in Chronic Pancreatitis

Start date: February 2007
Phase: N/A
Study type: Observational

Our aim in this study is to find out if we can locate the similar reduction in the recruitment of macrophages, remodeling of vasculature and do they correlate in the number and area of the islets in pancreas as in the mouse model.

NCT ID: NCT00490854 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study for Patients With Type 2 Diabetes Mellitus

Start date: July 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.

NCT ID: NCT00490672 Completed - Hypertension Clinical Trials

Community Based Multiple Risk Factors Intervention Strategy

CORFIS
Start date: August 2007
Phase: Phase 4
Study type: Interventional

Randomized controlled trial of CORFIS Programme. The study objectives are as follows: 1. To determine the efficacy of a community based multiple risk factors interventional strategy (CORFIS) for a treatment period of 6 months in patients on treatment for HT, DM or HL. 2. The intervention shall consist of a purpose design and systematically organized disease management program that employ multi-faceted interventions incorporating various specific measures to maximize both clinician (as investigator) adherence with treatment guideline and patient adherence with treatment.