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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: vildagliptin

• Registration Number: NCT01426802
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vildagliptin 50 bid	vildagliptin	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Investigative site; 🇪🇬 Cairo, Egypt