Glycemic Holter Study (Continuous Glucose Monitoring) - (OPTIMA)

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193296

CLAF237AFR02

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin