Status:
COMPLETED
Glycemic Holter Study (Continuous Glucose Monitoring) -
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01193296
Start Date
June 1 2010
End Date
June 1 2011
Last Update
May 4 2012
Active Locations (7)
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1
Investigative Site
Bondy, France
2
Investigative Site
Corbeil, France
3
Investigative Site
Marseille, France
4
Investigative Site
Nancy, France