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NCT01426802 Clinical Trial

Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:
A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01426802
Other study ID # CLAF237AEG01
Secondary ID
Status Completed
Phase Phase 4
First received July 1, 2011
Last updated February 23, 2017
Start date October 2010
Est. completion date April 2011

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who sign the informed consent

- HbA1c in the range of > 7 to =10.5% at Visit 1

- Ability to comply with all study requirements

Exclusion Criteria:

- Pregnant or lactating women

- Serious cardiovascular disorders

- Liver/renal disease or dysfunction

- Anti-diabetic other than metformin, thiazolidine, or a-GI or insulin

- Laboratories values abnormalities as defined by the protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• vildagliptin
Drug 50mg vildagliptin bid

Locations
Country Name City State
Egypt Investigative site Cairo

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the safety and tolerability of vildagliptin 50 mg bid Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety. 12 weeks
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