Study of efficacy and safety of Vildagliptin as add-on insulin therapy in T2DM patients
Phase 4
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT1080222358
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
*Confirmed diagnosis of T2DM by standard criteria.
*HbA1c >= 7.0 to <= 10% at Visit 1.
*Age: >= 20 to < 75 years old at Visit 1.
*BMI >= 20 to <= 35 kg/m2 at Visit 1.
Exclusion Criteria
*FPG >= 270 mg/dL (>= 15 mmol/L) at Visit 1.
*Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
*Significant heart diseases
*Hepatic disorder
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups [Time Frame: Baseline to 12 weeks]<br><br>HbA1c will be performed on a blood sample obtained and measured by HPLC performed at a central laboratory.
- Secondary Outcome Measures
Name Time Method