Type 2 Diabetes Mellitus Clinical Trial
Official title:
A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
| Status | Completed |
| Enrollment | 448 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of T2DM - On a stable dose of insulin as defined by the protocol - On a stable does of metformin (if applicable) as defined by the protocol - Age 18 to 80 years - HbA1c of 7.5 to 11.0% - Body Mass Index (BMI) 22 to 40 kg/m2 Exclusion Criteria: - Type 1 diabetes - Short-acting or rapid-acting insulin - Pregnancy or lactation - Evidence of serious diabetic complications - Evidence of serious cardiovascular complications - Laboratory value abnormalities as defined by the protocol - Other protocol-defined inclusion/exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Box Hill | |
| Australia | Novartis Investigative Site | Heidelberg Heights | |
| Australia | Novartis Investigative Site | Parkville | |
| Australia | Novartis Investigative Site #1 | Wollongong | |
| Australia | Novartis Investigative Site #2 | Wollongong | |
| Belgium | Novartis Investigative Site | Bonheiden | |
| Belgium | Novartis Investigative Site | Edegem | |
| Belgium | Novartis Investigative Site | Genk | |
| Belgium | Novartis Investigative Site | La Louviere | |
| Belgium | Novartis Investigative Site | Ronse | |
| Czech Republic | Novartis Investigative Site #1 | Ostrava | |
| Czech Republic | Novartis Investigative Site #2 | Ostrava | |
| Czech Republic | Novartis Investigative Site #3 | Ostrava | |
| Germany | Novartis Investigative Site | Asslar | |
| Germany | Novartis Investigative Site | Bensheim | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Einbeck | |
| Germany | Novartis Investigative Site #1 | Hamburg | |
| Germany | Novartis Investigative Site #2 | Hamburg | |
| Germany | Novartis Investigative Site #3 | Hamburg | |
| Germany | Novartis Investigative Site #4 | Hamburg | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site #1 | Kassel | |
| Germany | Novartis Investigative Site #2 | Kassel | |
| Germany | Novartis Investigative Site | Munchen | |
| Germany | Novartis Investigative Site | Neubukow | |
| Germany | Novartis Investigative Site | Saarlouis | |
| Germany | Novartis Investigative Site | Tubingen | |
| Guatemala | Novartis Investigative Site #1 | Guatemala City | |
| Guatemala | Novartis Investigative Site #2 | Guatemala City | |
| Guatemala | Novartis Investigative Site #3 | Guatemala City | |
| Guatemala | Novartis Investigative Site #4 | Guatemala City | |
| Guatemala | Novartis Investigative Site #5 | Guatemala City | |
| Hong Kong | Novartis Investigative Site #1 | Hong Kong | |
| Hong Kong | Novartis Investigative Site #2 | Hong Kong | |
| Hungary | Novartis Investigative Site #1 | Budapest | |
| Hungary | Novartis Investigative Site #2 | Budapest | |
| Hungary | Novartis Investigative Site | Dunaujvaros | |
| Hungary | Novartis Investigative Site | Nyiregyhaza | |
| Hungary | Novartis Investigative Site | Szeged | |
| India | Novartis Investigative Site | Indore | |
| India | Novartis Investigative Site | Jaipur | |
| India | Novartis Investigative Site | Karnal | |
| India | Novartis Investigative Site #2 | Mumbai | |
| India | Novartis Investigative Site #1 | Mumbia | |
| India | Novartis Investigative Site #1 | Nagpur | |
| India | Novartis Investigative Site #2 | Nagpur | |
| India | Novartis Investigative Site | Nasik | |
| India | Novartis Investigative Site #1 | Trivandrum | |
| India | Novartis Investigative Site #2 | Trivandrum | |
| Romania | Novartis Investigative Site | Alba-Iulia | |
| Romania | Novartis Investigative Site | Bucharest | |
| Romania | Novartis Investigative Site #1 | Oradea | |
| Romania | Novartis Investigative Site #2 | Oradea | |
| Romania | Novartis Investigative Site | Targu-Mures | |
| Slovakia | Novartis Investigative Site | Banska Bystrica | |
| Slovakia | Novartis Investigative Site #1 | Bratislava | |
| Slovakia | Novartis Investigative Site #2 | Bratislava | |
| Slovakia | Novartis Investigative Site #3 | Bratislava | |
| Slovakia | Novartis Investigative Site #1 | Kosice | |
| Slovakia | Novartis Investigative Site #2 | Kosice | |
| Slovakia | Novartis Investigative Site | Presov | |
| Slovakia | Novartis Investigative Site | Sturovo | |
| United Kingdom | Novartis Investigative Site | Carmarthen | |
| United Kingdom | Novartis Investigative Site #1 | Glasgow | |
| United Kingdom | Novartis Investigative Site #2 | Glasgow |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Australia, Belgium, Czech Republic, Germany, Guatemala, Hong Kong, Hungary, India, Romania, Slovakia, United Kingdom,
Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c reduction | 24 weeks | ||
| Secondary | HbA1c reduction in subpopulation treated with insulin and with metformin | 24 weeks | ||
| Secondary | HbA1c reduction in subpopulation treated with insulin and without metformin | 24 weeks | ||
| Secondary | Reduction in FPG (overall and subpopulations) | 24 weeks | ||
| Secondary | Responder rates (overall and subpopulations) | 24 weeks | ||
| Secondary | Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) | 24 weeks |
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