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NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes Clinical research trials and NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes. NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes clinical trial. Test subjects typically receive the most effective healthcare possible for their NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "N" Clinical Trials Conditions > NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes  NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes
NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes
For Condition: Diabetes Mellitus, Non-Insulin-Dependent
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn. One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly). The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over. The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 30 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: Subjects with Type 2 Diabetes 1. Signed and dated informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject. 2. Subjects diagnosed with type 2 diabetes according to the American Diabetes Association (ADA) criteria (6): fasting plasma glucose ?126 mg/dL (7.0 mmol/L) or 2-hour plasma glucose ? 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT). 3. Subjects with type 2 diabetes either newly diagnosed with at least 2 months of diet or on oral anti-diabetic monotherapy for at least 3 months. 4. Age 30-75 years inclusive. Body Mass Index 24 to 35 kg/m2 inclusive. Healthy Volunteers 1. The subject must give signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject. 2. Age 30-75 years inclusive. 3. Body Mass Index 24 to 35 kg/m2 inclusive. Must meet the ADA criteria for normal glucose tolerance (6): fasting plasma glucose below 110 mg/dL (6.1 mmol/L) and 2-hour plasma glucose < 140 mg/mL (7.8 mmol/L) during an OGTT.
Total Enrollment: 30
Location and Contact Information:
University of Michigan
Ann Arbor, Michigan, 48109
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00042-1749;
Study Start Date:
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013910
Other Diabetes Mellitus, Non-Insulin-Dependent Studies:
1. A Research Study to determine the safety and efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents with Type 2 Diabetes.
2. Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea
3. Treating Periodontal Infection: Effects on Glycemic Control in People with Type 2 Diabetes
4. Safety and Efficacy of INGAP-Peptide in Patients with Type 2 Diabetes
5. Evaluation of an Orally Administered Medication When Taken in Conjunction with Pramlintide
Related Studies:
Other Diabetes Mellitus, Non-Insulin-Dependent Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
NNC 90-1170 Mechanism of Action: A double-blind, randomized, single-center, placebo-controlled, crossover study to examine beta-cell responsiveness to graded glucose infusion in subjects with type 2 diabetes
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