Pilot study to assess the difference in glycemic profiles between vildagliptin and glimepiride using CGM device

ovartis Pharma Services AG0 sitesAugust 23, 2010

DrugsGalvus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma Services AG
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 23, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•Written informed consent must be obtained before any assessment is performed.
•Able to communicate well with the investigator, to understand and comply with the requirements of the study.
•Patients must be willing to comply with dietary recommendations throughout the study
•Willingness to perform required study and data collection procedures and adhere to operating requirements CGMS iPro Systems
•Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL\-Time and iPro Systems
•Type 2 diabetics stabilized on metformin monotherapy (stable dose for at least 4 weeks prior to Screening). The metformin dose should not be expected to change during the course of the study
•Agreement to maintain the same dose of metformin throughout the study.
•Patients must be diagnosed with type 2 diabetes mellitus at least 3 months prior to screening. Anti\-GAD antibodies will be determined during the screening period. Patients with a positive anti\-GAD antibodies assay will not be enrolled.
•HbA1c 7\.0\~8\.5% % at screening
•Male and female patients, age 18 to 70years of age inclusive

Exclusion Criteria

•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half\-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
•Use of any other antidiabetic agents (including sulfonylureas, thiazolidinediones, repaglinide, netaglinide, exenatide, liruglutide, sitagliptin, saxagliptin and insulin) other than stable dose of metformin.
•Use of any drugs that induce or inhibit CYP2C9 isozyme activity, including but not limited to Rifampin , fluconazole, fluvoxamine, gemfibrozil and voriconazole amiodarone, fluorouracil, metronidazole, miconazole, sulfamethoxazole barbiturates and cambamazepine
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
•History of tape allergies that have not been resolved
•Skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
•Significant unstable concomitant disease or complications of diabetes
•Significant illness unresolved within two (2\) weeks prior to initial dosing and/or acute infection(s) which may affect blood glucose control within 4 weeks prior to screening
•Evidence of clinically significant diabetic organ disease (renal, retinal, neurological, vascular) or complications (e.g., symptomatic autonomic neuropathy or gastroparesis) that would preclude study participation
•Patients with second degree AV block (Mobitz 1 and 2\); patients with third degree AV block