Glycemic Holter Study (Continuous Glucose Monitoring) -

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Sitagliptin Phosphate; Vildagliptin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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