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NCT01262586 Clinical Trial

Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

Type II Diabetes Mellitus Clinical Trial

Official title:
Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01262586
Other study ID # CLAF237A23151
Secondary ID 2010-021236-34
Status Completed
Phase Phase 3
First received December 16, 2010
Last updated November 16, 2016
Start date November 2010
Est. completion date March 2011

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

• Glimepiride

Locations
Country Name City State
Germany Novartis Investigative Site Mainz

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

He YL, Foteinos G, Neelakantham S, Mattapalli D, Kulmatycki K, Forst T, Taylor A. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Glycemic profiles between vildagliptin and glimepiride Baseline and treatment Day 5, 24hr continuous glucose measurements No
Secondary Glucose Fluctuation before and during treatment Baseline and treatment Day 5, 24hr continuous measurements No
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