Clinical trial NCT01582230: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard 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:

Patients fulfilling any of the following criteria are not eligible for participation in the study

* 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

Primary outcomes:
measure: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population
timeFrame: Baseline and every study visit up to 24 weeks
measure: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population
timeFrame: Baseline and every study visit up to 24 weeks
Secondary outcomes:
measure: Number of patients with adverse events, serious adverse events and death on over all population
timeFrame: 24 weeks
measure: Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population
timeFrame: Baseline, week 24
measure: Percentage of patients meeting responder criteria after 24 weeks treatment on overall population
timeFrame: After 24 weeks
measure: Number of patients with adverse events, serious adverse events and death on Chinese population
timeFrame: 24 weeks
measure: Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population
timeFrame: Baseline, week 24
measure: Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population
timeFrame: After 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Changsha City
country: China
facility: Novartis Investigative Site
state: Hunan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Wu Xi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Jinan
country: China
facility: Novartis Investigative Site
state: Shandong
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Metro Manila
country: Philippines
facility: Novartis Investigative Site
city: Pasay City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.