Type 2 Diabetes — Sitagliptin in Prevention of Type 2 Diabetes Mellitus
Citation(s)
1 Ramachandran A, Ronald Ma, Snehalatha C. Diabetes in Asia. 2009 Lancet Oct;DOI:10.1016/S0140-6736(09)60937-5. 2.Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Shetty SB, Nanditha A, Ramachandran A. Changes in insulin secretion and insulin sensitivity in relation to the glycemic outcomes in subjects with impaired glucose tolerance in the Indian Diabetes Prevention Programme-1 (IDPP-1).Diabetes Care. 2009 Oct;32(10):1796-801. 3.Ramachandran A, Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Catherin Seeli A, Samith Shetty A. Pioglitazone does not enhance effectiveness of life style modification in prevening conversion of impaired glucose tolerance to diabetes in Asian Indians-Results of Indian Diabetes Prevention Programme- (IDPP-2).Diabetologia 2009; 52: 1019 - 1026. 4.Ramachandran A, Snehalatha C. Cardiovascular risk factors in normoglycaemic Asian Indian population-Impact of urbanization. Diabetologia 2009 52; 596-599.
Does the DPP4 Inhibitor Sitagliptin Have a Role in Preventing Type 2 Diabetes- A Randomised Controlled Study.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.