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
NCT ID: NCT01582230
Last Updated: 2013-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
293 participants
INTERVENTIONAL
2012-04-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vildagliptin
Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.
Vildagliptin
Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks
Placebo
Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.
Placebo
Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
Interventions
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Vildagliptin
Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks
Placebo
Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* C-peptide \>0.6 ng/ml (\>0.20 nmol/L).
* HbA1c ≥7.5 to ≤11% at Visit 1
* Treatment with stable, once or twice daily doses (maximum dose of \< 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
* Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
* Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit
Exclusion Criteria
* Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
* Pregnant or lactating women
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Current diagnosis of congestive heart failure (NYHA III or IV).
* Myocardial infarction (MI) within the past 6 months
* Liver disease such as cirrhosis or chronic active hepatitis
Other protocol defined inclusion/excusion criteria may apply
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Pasay, Philippines, Philippines
Novartis Investigative Site
Metro Manila, , Philippines
Novartis Investigative Site
Quezon City, , Philippines
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Bangkok, Bangkok, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Khon Kaen, , Thailand
Countries
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References
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Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.
Other Identifiers
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CLAF237A23155
Identifier Type: -
Identifier Source: org_study_id