Status:
COMPLETED
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study ...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range of 20-35 kg/m\^2
Exclusion
- Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01811485
Start Date
May 1 2013
End Date
February 1 2014
Last Update
February 23 2015
Active Locations (30)
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1
Novartis Investigative Site
Chikushino-shi, Fukuoka, Japan, 818-0083
2
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 810-0014
3
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 819-0006
4
Novartis Investigative Site
Iizuka, Fukuoka, Japan, 820-8505