Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
- Registration Number
- NCT01497522
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin Vildagliptin In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily. Placebo Placebo In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
- Primary Outcome Measures
Name Time Method Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups Baseline to 12 weeks HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
- Secondary Outcome Measures
Name Time Method Percentage of patients meeting Responder rates in HbA1c 12 weeks Responder rates will be categorized by predefined HbA1c value at 12 weeks :
* Endpoint HbA1c ≤ 6.5%
* Endpoint HbA1c ≤ 7%
* Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8%Change from baseline in Fasting plasma glucose (FPG) at 12 weeks Baseline to 12 weeks FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.
Number of patients with adverse events (including hypoglycemia), serious adverse events and death 12 weeks The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses Baseline to 12 weeks HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Kyoto, Japan