Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01426802
First received: July 1, 2011
Last updated: August 30, 2011
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2011 | ||||
| Last Updated Date | August 30, 2011 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the safety and tolerability of vildagliptin 50 mg bid [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01426802 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin | ||||
| Official Title ICMJE | A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE | Drug: vildagliptin
Drug 50mg vildagliptin bid |
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| Study Arm (s) | Experimental: Vildagliptin 50 bid
Intervention: Drug: vildagliptin |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Egypt | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01426802 | ||||
| Other Study ID Numbers ICMJE | CLAF237AEG01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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