Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
Overview[ - collapse ][ - ]
| Purpose | This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day. |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: vildagliptin/metformin |
| Phase | Phase 4 |
| Sponsor | Novartis |
| Responsible Party | Novartis |
| ClinicalTrials.gov Identifier | NCT01196546 |
| First Received | August 28, 2010 |
| Last Updated | May 3, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 28, 2010 |
|---|---|
| Last Updated Date | May 3, 2012 |
| Start Date | March 2010 |
| Estimated Primary Completion Date | October 2011 |
| Current Primary Outcome Measures | HbA1c reduction [Time Frame: 24 weeks after treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM) |
|---|---|
| Official Title | Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin |
| Brief Summary | This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: vildagliptin/metformin |
| Study Arm (s) | Experimental: Vildagliptin/metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 161 |
| Estimated Completion Date | October 2011 |
| Estimated Primary Completion Date | October 2011 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months - The patient is required to have HbA1c 6.5-11.0% - BMI in the range of 22-48 kg/m2 Exclusion Criteria: - Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%) - Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months - Congestive heart failure requiring pharmacologic treatment - Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention - Liver disease such as cirrhosis or chronic active hepatitis |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Thailand |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01196546 |
|---|---|
| Other Study ID Numbers | CLMF237ATH01 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Novartis |
| Study Sponsor | Novartis |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| King Chulalongkorn Memorial Hospital | Bangkok, Thailand |
|---|---|
| BMA Medical College and Vajira Hospital | Bangkok, Thailand |
| Siriraj Hospital | Bangkok, Thailand |
| Police General Hospital | Bangkok, Thailand |
| Phamongkutklao Hospital | Bangkok, Thailand |
| Khon Kaen Hospital | Khon Kaen, Thailand |
| Fort Suranaree Hospital | Nakhon Ratchasima, Thailand |
| Maharat Nakhon Ratchasima Hospital | Nakhon Ratchasima, Thailand |