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Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione Clinical research trials and Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione. Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione  Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione
Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione
For Condition: Diabetes Mellitus, Non-Insulin-Dependent
Status: Completed
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: Assess the efficacy and safety of Amaryl when added to Metformin and TZD
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients must have given their signed informed consent. - Males or females between 18 and 80 years old. Female patients must be surgically sterile, post-menopausal, or using an accepted method of birth control (i.e., oral contraceptives, intrauterine device, Norplant® system, Depo Provera®, or a spermicide and condom). Female patients of childbearing potential must have a negative serum pregnancy test and be advised not to become pregnant during the study. - At least 1 year history of NIDDM and performing home blood glucose monitoring. - Patients must have BMI of � 26 to � 42 kg/m2 at baseline (week 0). - Patients must have HbA1C � 7.5% but � 9.5% at screen (week -4). - Patients must have evidence of insulin secretory capacity (fasting C-peptide concentration > or equal to 0.27 nmol/l during the stabilization period). - Patients must have FPG > 130 mg/dl but < 235 mg/dl prior to (within 48-72 hours) randomization at Visit 1 Week 0. - Patients must be receiving as their current diabetic therapy stable doses of metformin (at dose of 1.0-2.5gm/day), or metformin extended release at a maximum dose of 2 gm/day and a half maximum to a maximum dose of thiazolidinedione for at least 3 months. - Patients must be able to understand and willing to adhere to and be compliant with the study protocol. Exclusion Criteria - Patients who require insulin therapy or are currently on other sulfonylureas. - Patients with a history of hypersensitivity to sulfonylureas. - Patients with past history of severe hypoglycemia reaction on their current antidiabetic therapy requiring medical attention. - Patients with a history of acute metabolic complications such as hyperosmolar coma or ketonuria. - Patients with clinically significant abnormal baseline laboratory values (hematology, blood chemistry or urinalysis) which define a disease or condition, which in the opinion of the investigator may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate and complete the study. Should there be a laboratory value which, upon initial screening, is substantially outside the normal range, the test should be repeated. - Patients who had an increase in their thiazolidinedione medication within 2 months of entering the study (Visit 0). - Patients who had an increase in the metformin medication within 1 month of entering the study (Visit 0). - Patients whose body weight has changed more than 2% for patients < 250 pounds or 3% for patients � 250 pounds, during the 4 week stabilization period when compared to the weight at the screening visit 0 (week - 4). - Patients with acute infections. - Patients who have received any drug (i.e. a chemotherapy agent) with a well-defined potential for toxicity to a major organ system during the three months prior to the study. - Patients with clinically significant renal or hepatic disease (i.e. ALT > 2.5 x upper limit of normal) or gastrointestinal disorders that may interfere with absorption of the study drugs. - Patients who are allergic to sulfonamides and excipients. - Patients with any history of alcohol or drug abuse. - Pregnant or lactating females will be excluded. - Patients with a history of psychosis, emotional or intellectual problems that could impair the ability of the patient to participate in the study or to complete the study. - Patients who have participated in any investigational study within 30 days prior to Visit 0.
Total Enrollment: 160
Location and Contact Information:
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
United States
Additional Information:
Study ID Numbers: HOE 490/4033;
Study Start Date: January 2001
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044447
Other Diabetes Mellitus, Non-Insulin-Dependent Studies:
1. Education and Group Support for Diabetic Hispanics
2. Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes
3. Identification and therapy efficacy of Type 2 diabetes in Hispanic patients
4. Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
5. Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione
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Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients unresponsive to Maximum Dose Metformin & Thiazolidinedione
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