Type 2 Diabetes Mellitus
The aim of the study is to investigate the long-term impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with T2DM and to compare outcomes against placebo, on a background of standard of care.
This study consists of two parts, Part I and Part II. The purpose of Part I of the study is to assess the efficacy and safety of MK-8931 compared with placebo administered for 78 weeks in the treatment of Alzheimer's Disease (AD). The primary study hypotheses for Part I are that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score. The first approximately 400 participants entering Part I of the study are identified as the Safety Cohort. Participants who complete Part I of the study may choose to participate in Part II, which is a long term double-blind extension to assess efficacy and safety of MK-8931 administered for up to an additional 260 weeks.
Type 2 Diabetes Mellitus
This study will determine whether resting beta cells (cells in the pancreas that produce insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus (t2dm) to make insulin. Beta cells can rest by giving patients insulin shots. The study will also examine how teenagers with t2dm feel about having diabetes and explore differences between young people with and without t2dm.
This study includes patients 12 to 25 years of age with t2dm who are overweight and who were diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or who are overweight are also eligible. Candidates are screened with a medical history, physical examination and laboratory tests.
Participants with t2dm are assigned to one of two groups. Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a pump under the skin for 2 weeks. During these two weeks, all participants have the following tests:
-Frequent blood sugar checks.
-Oral glucose tolerance test (routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution).
-Arginine stimulation to test the response of the body to arginine, a normal ingredient of food that stimulates the release of insulin. Two catheters are placed into veins in the arms, one to administer a liquid containing arginine, the other to draw the blood samples.
-Ultrasound of the blood vessels in the neck to check for hardening of the arteries.
-Metabolism test to measure the amount of oxygen used during rest. The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes.
-MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and end of the study)
-DEXA scan to determine percent body fat.
-Tests to explore quality of life and feelings about health, work or school, friends and family.
-Exercise testing on a treadmill or stationary bicycle.
-Genetic studies for information on diabetes and obesity.
Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan, psychological testing, exercise testing, and genetic testing.