Glycemic Holter Study (Continuous Glucose Monitoring) -

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin; Drug: Sitagliptin

• Registration Number: NCT01193296
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	-
Sitagliptin	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Glycemic control assessed through CSGM	8 weeks
Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks	8 weeks
Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration	8 weeks

Trial Locations

Locations (1)

Investigative Site; 🇫🇷 Venissieux, France