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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00228865 Terminated - Diabetes Mellitus Clinical Trials

Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1

Start date: June 2003
Phase: Phase 2/Phase 3
Study type: Interventional

To determine if restoring normal metabolic function in patients with either Type I or Type II Diabetes can improve overall cognitive function. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion and high amounts of oral glucose consumption.

NCT ID: NCT00226330 Terminated - Clinical trials for Diabetes Mellitus, Type 2

GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

NCT ID: NCT00225225 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Rosiglitazone-Induced Weight Gain

Start date: October 2002
Phase: N/A
Study type: Interventional

Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-mediated glucose disposal. However, the improvement of glycemic control seen with TZDs may be blunted in the long run by weight gain. Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It is generally assumed that an increase in adipocyte differentiation is the cause of weight gain in association with TZD treatment which may limit their use. Increased body weight assumed to compromise the positive effects of treatment. There is also a theoretical concern that, with the development of new adipocytes, future weight loss may be difficult. However, if weight gain is primarily due to failure to adjust caloric intake in proportion to the decrease in urinary glucose loss, it is totally preventable. It has been previously shown that improvement of glycemia favored weight gain by decreasing the energy loss in the urine as glucose. Severity of weight gain appears to be proportional to the level of glycemic control achieved. The overall goal of the proposed research is to provide the experimental evidence for the later alternative by showing that the modest weight gain that takes place in association with effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due to its therapeutic efficacy. More specifically, by decreasing the caloric intake in proportion to a decrease in urinary glucose loss associated with improved glycemic control, we will be able to prevent significant weight gain following Rosiglitazone treatment. In order to provide an optimal dietary modification that can be universally applied to TZD-treated patients in clinical practice, we will have a group with a fixed amount of caloric restriction per day. It will be the first randomized controlled trial of a potential strategy for prevention of weight gain associated with thiazolidinediones.

NCT ID: NCT00220831 Terminated - Diabetes Clinical Trials

Prevention of Cardiovascular Complications in Diabetic Patients With Vitamin E Treatment

Start date: April 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients, who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute MI and Stroke.

NCT ID: NCT00215735 Terminated - Diabetes Clinical Trials

Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

Start date: June 2004
Phase: N/A
Study type: Interventional

Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

NCT ID: NCT00214591 Terminated - Clinical trials for Diabetes Mellitus, Type 2

GALLANT 5 Tesaglitazar Versus Metformin

Start date: August 2004
Phase: Phase 3
Study type: Interventional

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

NCT ID: NCT00214565 Terminated - Clinical trials for Diabetes Mellitus, Type 2

GALLANT 6 Tesaglitazar vs. Pioglitazone

Start date: August 2004
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

NCT ID: NCT00212004 Terminated - Diabetes Mellitus Clinical Trials

Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)

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

To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction

NCT ID: NCT00209417 Terminated - Diabetes Mellitus Clinical Trials

Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

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

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

NCT ID: NCT00203632 Terminated - Diabetes Mellitus Clinical Trials

Glitazones and Endothelial Function (GATE)

Start date: September 2003
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the addition of rosiglitazone to subjects with fair glucose control on other oral agents improves endothelial function, a surrogate marker of vascular health. It is hypothesized that improving whole body insulin sensitivity with combination therapy including rosiglitazone will restore the vascular actions of insulin and improve endothelium-dependent vasomotion more effectively than placebo in patients with diabetes mellitus.