Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01262586
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Drug: Vildagliptin; Drug: Glimepiride	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin	Drug: Vildagliptin
Active Comparator: Glimepiride	Drug: Glimepiride

Outcome Measures

Primary Outcome Measures

1. Change in Glycemic profiles between vildagliptin and glimepiride [Baseline and treatment Day 5, 24hr continuous glucose measurements]

Secondary Outcome Measures

1. Glucose Fluctuation before and during treatment [Baseline and treatment Day 5, 24hr continuous measurements]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetes patients on stable metformin

• 18-70 years old

• Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

• Type 2 diabetes patients on any other antidiabetic treatment

• Patients listed in other trials

• Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Mainz		Germany

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: NCT01262586
• Other Study ID Numbers: CLAF237A23151; 2010-021236-34
• First Posted: Dec 17, 2010
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Novartis Pharmaceuticals: Type II Diabetes Mellitus; Vildagliptin; Glimepiride; Continuous glucose monitoring
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glimepiride; Vildagliptin

Study Results

No Results Posted as of Nov 18, 2016