Eligible patients may enter the study at visit 1 according to the inclusion/exclusion criteria. At the screening visit, patients will enter a single blind placebo run-in period to establish baseline characteristics. Patients must have been stable on sulphonylurea therapy for at least 2 months prior to the screening visit to be included. For the duration of the run-in period, patients will receive BRL 49653C placebo in addition to their constant dose of sulphonylurea. Patients eligible to enter the double-blind phase of the study will be randomized in equal numbers at visit 2, to one of two treatment groups (BRL 49653C 2 mg bid. or placebo bid). Patients will then continue to take their study medication arid the constant dose of sulphonylurea through visits 3 to 8 (weeks 4 to 24).

Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy

BRL 49653C 2 mg bid or placebo bid through weeks 1 to 24.

BRL 49653C

Placebo

National Taiwan University Hospital

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes

A Double-blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of BRL 49653C With Concurrent Sulphonylurea Therapy, When Administered to Patients With Non-insulin Dependent Diabetes Mellitus.

Primary: Change from baseline for Hb A1c at week 24.
Secondary: Mean change from baseline for:
fasting plasma glucose,insulin levels, immune reactive,lipid levels (ie.total cholesterol, HDL-cholesterol, LDL cholesterol, triglycerides), body weight (WHR), vital signs (systolic, diastolic blood pressure and heart rate)

Physical examination, adverse experiences, laboratory safety data, ECG parameters

replace high fat, energy dense foods with foods rich in whole grains, fruits and vegetables. The macronutrient distribution of this diet will be approximately 55% carbohydrate, 15% protein and 30% fat. Individuals will also be instructed to reduce sodium intake to < 2300 mg / day and in individuals with hypertension, < 1500 mg / day.

restrict carbohydrate consumption to < 20 grams / day while not restricting caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' to increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily

Metabolic Syndrome

restrict carbohydrate consumption to < 20 grams / day while not restricting their caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily

Low carbohydrate diet

St. Paul's Hospital

The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

The ACT-OUT Trial: ACTivity OUTcomes Based on the Consumption of a High Carbohydrate or High Fat Diet in Patients With Metabolic Syndrome

activity counts per minute;
time spent in light and moderate to vigorous physical activity;
activity based energy expenditure using previously validated equations

total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, apolipoprotein B, apolipoprotein A1

hyperinsulinism/huvudvärk

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes

The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

Den mest kompletta databasen med medicinska örter som stöds av vetenskapen