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Type 2 Diabetes clinical trials

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NCT ID: NCT01095653 Completed - Type 2 Diabetes Clinical Trials

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

NCT ID: NCT01094899 Completed - Type 2 Diabetes Clinical Trials

Abnormal Structure and Bone Density in Diabetes

Start date: March 10, 2010
Phase: N/A
Study type: Interventional

Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities, fractures and final stage of Charcot foot. These anomalies are favored by the presence of peripheral neuropathy and plasma levels of advanced glycation end products higher than in diabetic subjects without bone abnormalities. The objectives of this research are to evaluate these anomalies quantitative and qualitative bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone mineral density as realized in clinical practice in a defined population of patients with type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral neuropathy and the rate of advanced glycation end products of proteins and reference to parameters of chronic inflammation and oxidative stress to better understand the pathophysiology and target a population at risk. The importance of this study is paramount in the management of diabetic foot. Indeed for the moment we are dealing primarily the consequences of diabetes impact bone when bone deformities have appeared with their attendant disability and the risk of recurrent infections in areas of friction in this fragile environment. The ultimate goal is to target people with diabetes have abnormal bone subclinical and take care to avoid changes to bone deformities and find ways to treat them.

NCT ID: NCT01093794 Completed - Type 2 Diabetes Clinical Trials

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Start date: April 2010
Phase: Phase 1
Study type: Interventional

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

NCT ID: NCT01091909 Completed - Type 2 Diabetes Clinical Trials

Post-extraction Wound Healing in Patients With Type 2 Diabetes

PEWHPD
Start date: March 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate clinical healing after dental extraction and the occurrence of surgical complications in patients with type 2 diabetes and compare with non-diabetic patients or control, taking into account laboratory data such as blood count, glycated hemoglobin (HbA1) and immunological profile of the patients.

NCT ID: NCT01089569 Completed - Type 2 Diabetes Clinical Trials

Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

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

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 insulin glargine and exenatide to metformin.

NCT ID: NCT01089205 Completed - Type 2 Diabetes Clinical Trials

Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions. Study Design: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study

NCT ID: NCT01089192 Completed - Type 2 Diabetes Clinical Trials

Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fasting Conditions. Study Design: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study

NCT ID: NCT01089179 Completed - Type 2 Diabetes Clinical Trials

Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single- Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 500 mg Tablet (Reference formulation, Bristol- Myers Squibb company, USA) in Healthy Volunteers under Fed Conditions. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment, Crossover Study under fed condition.

NCT ID: NCT01089166 Completed - Type 2 Diabetes Clinical Trials

Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition

Start date: n/a
Phase: Phase 1
Study type: Interventional

Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition. Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.

NCT ID: NCT01087567 Completed - Type 2 Diabetes Clinical Trials

INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes

INSPIRE
Start date: July 2010
Phase: Phase 4
Study type: Interventional

T2DM has become an American Epidemic. Currently 8% of the US population has diabetes and rates may be as high as 33% by the year 2050 (1). Although there are many treatment options for people with T2DM, none have been proven in humans to prevent the defects in insulin secretion (2) and insulin action (3) and beta cell dysfunction (4) that result with very high glucose levels and typically worsen as the disease progresses. Any treatment that could delay the progression of pancreatic beta cell failure (as measured by the need for rescue therapy with oral agents) would be a significant advancement in diabetes treatment. Insulin therapy is appropriate at any point in T2DM disease progression, but it is commonly only used as a rescue therapy after failure of oral therapies. A number of outpatient insulin titration protocols have been shown to be safe and effective and speed patient's ability to gain glucose control (5-8). Recent studies have shown that initiation of insulin at onset of T2DM is beneficial at achieving early and long-term glucose control (6-9). However these protocols have used intravenous human insulin in the in-patient setting, continuous subcutaneous insulin by insulin pump or older human insulins in the out-patient setting. Many of these protocols are unlikely to be utilized in routine patient care. To date, no "insulin first" studies have been published with analog insulins in an outpatient basal-bolus regimen with patient driven titration.