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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582230
• Other study ID #: CLAF237A23155
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: August 29, 2013
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: States Food and Drug AdministrationPhilippines: Department of Health; Bureau of Food and DrugsSingapore: Health Products Regulation Group (HPRG), Health Sciences AuthorityThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Changsha City	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Wu Xi	Jiangsu
China	Novartis Investigative Site	Xi'an	Shanxi
Philippines	Novartis Investigative Site	Metro Manila
Philippines	Novartis Investigative Site	Pasay City
Philippines	Novartis Investigative Site	Quezon City
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

China,  Philippines,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population	HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.	Baseline and every study visit up to 24 weeks	No
Primary	Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population	HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.	Baseline and every study visit up to 24 weeks	No
Secondary	Number of patients with adverse events, serious adverse events and death on over all population	Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.	24 weeks	Yes
Secondary	Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population	FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.	Baseline, week 24	No
Secondary	Percentage of patients meeting responder criteria after 24 weeks treatment on overall population	Responder rate will be analyzed in the following categories: Endpoint HbA1c = 6.5%; Endpoint HbA1c < 7%; Endpoint HbA1c <7% in patients with baseline HbA1c = 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed	After 24 weeks	No
Secondary	Number of patients with adverse events, serious adverse events and death on Chinese population	Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.	24 weeks	Yes
Secondary	Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population	FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.	Baseline, week 24	No
Secondary	Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population	Responder rate will be analyzed in the following categories: • Endpoint HbA1c = 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c = 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed	After 24 weeks	No