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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01426802
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 25.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: vildagliptin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin 50 bid	Drug: vildagliptin; Drug 50mg vildagliptin bid

Outcome Measures

Primary Outcome Measures

1. Evaluate the safety and tolerability of vildagliptin 50 mg bid [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 α-GI or insulin

• Laboratories values abnormalities as defined by the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative site	Cairo		Egypt

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01426802
• Other Study ID Numbers: CLAF237AEG01
• First Posted: Aug 31, 2011
• Last Update Posted: Feb 27, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis Pharmaceuticals: metformin; vildagliptin; T2DM
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vildagliptin

Study Results

No Results Posted as of Feb 27, 2017