Status:
COMPLETED
Phase 4 Study in the Elderly Patients With T2DM
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Elderly
Eligibility:
All Genders
65-80 years
Phase:
PHASE4
Brief Summary
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated wi...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
- HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.
Exclusion
- Age \> 80 yrs
- BMI \< 22 and ≥ 45 kg/m2
- Secondary T2 DM
- Hepatic failure, moderate/severe renal failure (Cl \< 50 ml/min) and CHF III \& IV
- ASAT / ALAT \> 3 ULN, creatinine clearance \< 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01238978
Start Date
October 1 2010
End Date
December 1 2011
Last Update
February 23 2017
Active Locations (15)
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1
Novartis Investigative Site
Armentières, France, 59208
2
Novartis Investigative Site
Brest, France, 29200
3
Novartis Investigative Site
Caen, France, 14000
4
Novartis Investigative Site
Creil, France, 60100