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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT01755442 Terminated - Diabetes Mellitus Clinical Trials

Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects

Start date: November 2012
Phase: Phase 1
Study type: Interventional

This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.

NCT ID: NCT01725672 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers

Start date: September 27, 2012
Phase: Phase 1
Study type: Interventional

This is a an open-label, randomized, single dose, four-way crossover, multi-stage study enrolling 20 healthy adult male and female subjects per part. This study consists of two separate parts (Part A and B) with each part comprising four treatment periods. Each subject will participate in all four treatment periods per part; Subjects may not enrol in both Parts A and B. This study is being conducted to compare the pharmacokinetics (PK) of two extended release fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses, 500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single dose and compared with the commercially available formulations of metformin extended release (XR) (GLUCOPHAGE ™ Sustained Release [SR]) and glimepiride immediate release (IR) (AMARYL ™). Part A of study will evaluate the bioavailability of a formulation comprising a film coated tablet containing release controlling polymers; and Part B will evaluate the bioavailability of a formulation comprising a tablet coated with release controlling polymers. In each part there will be 4 treatment periods. During each period, subjects will be randomized sequentially to receive a single dose of a reference treatment of 500 mg metformin XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR; and an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR.Serial PK sampling for up to 36 hours and safety assessments will be performed. Each period will be separated by a washout period of at least 5 days and a follow-up visit will occur 14 days after the last dose of study drug.

NCT ID: NCT01722474 Terminated - Healthy Clinical Trials

Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.

ASI-2012
Start date: October 2012
Phase: N/A
Study type: Interventional

The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational device under development for the non-invasive assessment of arterial stiffness. The ASI Device is considerably smaller and more cost effective than its commercially available counterparts. As the device is readily portable, it is intended to be targeted for use in the community (or at home), as opposed to within the hospital or clinic setting only. However, as the device is still under development, it is not known whether it is capable of determining arterial stiffness with the same sensitivity and consistency as those already in commercial use. An added variable is the fact the sensor for the ASI Device is located on the fingertip. Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic purposes. The ASI Device has not been tested against other instruments capable of providing similar measurements. Therefore, a clinical trial to compare the ASI Device against similar devices is necessary. The study will compare measurements of arterial stiffness and other central haemodynamic parameters obtained with the ASI Device against similar measurements from devices that have already been approved for this purpose by Health Canada/United States Food and Drug Administration (FDA).

NCT ID: NCT01715012 Terminated - Diabetes Clinical Trials

Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This study is a randomized, double blind, placebo controlled trial at a single site. The primary objective is to evaluate the safety of ST266 in diabetic subjects with deep burns. The secondary objectives of this study are to (1) evaluate efficacy of ST266 in healing burns and (2) evaluate whether treatment with ST266 results in less scarring, in subjects with diabetes separately comparing healing of the skin graft and the skin graft donor site using ST266 plus a burn dressing versus placebo and a burn dressing.

NCT ID: NCT01690572 Terminated - Diabetes Mellitus Clinical Trials

Drug Eluting Balloon for Prevention of Constrictive Remodeling

Start date: October 2012
Phase: N/A
Study type: Interventional

Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.

NCT ID: NCT01631929 Terminated - Diabetes Clinical Trials

Two Bag System for Hydration in Diabetes

Start date: August 2012
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing the time needed to get the conditions to space hourly controls to controls every 4 hours, using the one bag system versus the two bags system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could determine changes in glucose IV administration. On using the classic one bag system each change determine a bag change. Using the two bag system allows to deliver the patient the appropriate glucose infusion in less time.

NCT ID: NCT01627899 Terminated - Diabetes Clinical Trials

One Touch VerioIQ US Clinical Outcomes Study

Start date: October 1, 2012
Phase: N/A
Study type: Interventional

Evaluation of the clinical benefits of One Touch VerioIQ system

NCT ID: NCT01579136 Terminated - Hypertension Clinical Trials

Do Home Monitors Improve Blood Pressure Control?

Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.

NCT ID: NCT01549769 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes

Start date: April 30, 2012
Phase: Phase 1
Study type: Interventional

This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes.

NCT ID: NCT01542242 Terminated - Clinical trials for Diabetes Mellitus Type 2

Liraglutide Use in Prader-Willi Syndrome

Start date: February 2012
Phase: Phase 4
Study type: Interventional

Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks. The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.