Type 2 Diabetes Mellitus Clinical Trial
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
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 161 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 78 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | BMA Medical College and Vajira Hospital | Bangkok | |
| Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
| Thailand | Phamongkutklao Hospital | Bangkok | |
| Thailand | Police General Hospital | Bangkok | |
| Thailand | Siriraj Hospital | Bangkok | |
| Thailand | Khon Kaen Hospital | Khon Kaen | |
| Thailand | Fort Suranaree Hospital | Nakhon Ratchasima | |
| Thailand | Maharat Nakhon Ratchasima Hospital | Nakhon Ratchasima |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c reduction | 24 weeks after treatment | ||
| Secondary | Proportion of patients who achieve target of HbA1c<6.5% at the end of study | 24 weeks after treatment | ||
| Secondary | To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles | 24 weeks after treatment |
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