Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Phase 4

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Vildagliptin; Drug: Sitagliptin

• Registration Number: NCT01398592
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%

Exclusion Criteria

FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	Experimental
Sitagliptin	Sitagliptin	Active comparator (drug)

Primary Outcome Measures

Name	Time	Method
demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin	14 days	Fasting Plasma Glucose measured on day 14.

Secondary Outcome Measures

Name	Time	Method
To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin	14 days	Fasting Plasma Glucose on day 14 analyzed descriptively.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Stuttgart, Germany