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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT01334606 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units

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

The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily injections of greater than 40 units of insulin. Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.

NCT ID: NCT01333514 Terminated - Diabetes Clinical Trials

Carbohydrate Consumption as a Factor in Aspart Dosing

CARB
Start date: April 2011
Phase: Phase 4
Study type: Interventional

Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing meal-time insulin is based on the fraction of the total meal-tray eaten which includes proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a patient who consumes a portion of mainly proteins and fats on their trays or an underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high blood sugars can follow respectively. Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of carbohydrates consumed will result in better sugar control compared to the usual practice of dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.

NCT ID: NCT01315808 Terminated - Clinical trials for Diabetes Mellitus Type 2

Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM

Start date: March 2011
Phase: N/A
Study type: Observational

The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.

NCT ID: NCT01303315 Terminated - Clinical trials for Diabetes Mellitus, Type 2

TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy

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

To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy

NCT ID: NCT01286090 Terminated - Diabetes Mellitus Clinical Trials

An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus

Start date: July 2003
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effectiveness of cisapride at improving symptoms associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.

NCT ID: NCT01244646 Terminated - Clinical trials for Diabetes Mellitus Type 2

Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives.

Start date: December 2010
Phase: N/A
Study type: Observational

1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus will receive additional treatment with a sulfonylurea (SU) derivative. At the start and at 3 and 6 months, during regular visits to the patient's General Practitioner, the patients will complete a series of questionnaires (Patient Reported Outcomes, PROs) directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment compliance and at general wellbeing. These PROs are the worry subscale of the Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events and body weight changes will be assessed and the level of adherence to treatment will be investigated. 2. Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last month), informed consent provided, in whom a SU therapy is added. Patients with Type 1 diabetes and with secondary diabetes will be excluded, and patients unable to understand and complete the questionnaires. 3. Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6 months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events, changes in body weight and level of compliance will be addressed. 4. The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to 6 months in case of withdrawal after 3 months. Changes in outcome variables will be analysed by modelling time and potential dummy variables in a Generalized Estimating Equations analysis. 5. Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0 to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships between (changes in) the different questionnaires, such as with hypoglycemia symptoms, weight (changes) and treatment compliance will be evaluated. A search is done for baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic symptoms, hypoglycemic events and weight changes.

NCT ID: NCT01238484 Terminated - Diabetes Mellitus Clinical Trials

Ankle Equinus Contracture Treated With Dynamic Splinting

Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.

NCT ID: NCT01223651 Terminated - Clinical trials for Diabetes Mellitus, Type 1

Performance of Continuous Glucose Monitoring Systems at Altitude

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

10 healthy volunteers will undergo the controlled lowering of their blood glucose level at sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea level.

NCT ID: NCT01222078 Terminated - Clinical trials for Diabetes Mellitus, Type 1

Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus

Start date: November 22, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus

NCT ID: NCT01213563 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Management of Type 2 Diabetes After Gastric Bypass Surgery

Start date: January 2009
Phase: N/A
Study type: Interventional

Gastric bypass surgery has been proposed as an effective treatment strategy for type 2 diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately after surgery have not been established. The investigators designed an algorithm to achieve good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.