Glycemic Holter Study (Continuous Glucose Monitoring) - (OPTIMA)
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Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months
Age >= 80 years
BMI <= 22 and >=40 kg/m2
Secondary T2 DM
Hepatic failure, ASAT/ALAT>3 ULN, and moderate/severe renal failure (CI < 50 ml/min) CHF III & IV
Other protocol-defined inclusion/exclusion criteria may apply