Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00860288

Purpose

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin + metformin Drug: Placebo + metformin Drug: Sitagliptin + metformin	Phase II Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. [ Time Frame: 76 weeks ] [ Designated as safety issue: Yes ]
To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2380
Study Start Date:	February 2009
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vildagliptin Dose 1: Experimental	Drug: Vildagliptin + metformin
Vildagliptin Dose 2: Experimental	Drug: Vildagliptin + metformin
Placebo: Placebo Comparator	Drug: Placebo + metformin
Sitagliptin: Active Comparator	Drug: Sitagliptin + metformin

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18-78 years old inclusive at Visit 1
T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit
Patient agreement to maintain same dose of metformin throughout study
HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria:

Pregnant or nursing (lactating) women
FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860288

Contacts

Contact: External Affairs

862-778-8300 (US)

Show 187 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLAF237B2224
Study First Received:	March 10, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00860288 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Federal Ministry for Health and Women; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Canada: Health Canada; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ministry of Health and Welfare; Guatemala: Ministerio de Salud pública y Asistencia Social; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Ministry of Health; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: The Italian Medicines Agency; Korea: Food and Drug Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Ministry of Health; Norway: Norwegian Medicines Agency; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Health Sciences Authority; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

Type 2 Diabetes
vildagliptin

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus
Endocrine System Diseases
Vildagliptin
Sitagliptin
Protease Inhibitors

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Vildagliptin

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009