VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus - Full Text View

Purpose

The purpose of this study is to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with T2DM.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Placebo to vildagliptin Drug: vildagliptin Drug: Metformin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 5-year Study to Compare the Durability of Glycemic Control of a Combination Regimen With Vildagliptin & Metformin Versus Standard-of-care Monotherapy With Metformin, Initiated in Treatment-naïve Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of loss in glycemic control over time [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Time to initial treatment failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of loss in glycemic control in fasting plasma glucose [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2 [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Rate of loss of beta cell function from baseline to end of study ( 5 years) [ Time Frame: From baseline to end of study (5 years) ] [ Designated as safety issue: No ]
Number patients with adverse events, death and serious adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Rate of loss in glycemic control in over time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Rate of change in insulin sensitivity from baseline to end of study (5 years) [ Time Frame: From baseline to end of study (5 years) ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	January 2012
Estimated Study Completion Date:	February 2019
Estimated Primary Completion Date:	February 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Metformin + vildagliptin	Drug: vildagliptin Patients will be instructed to take one tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food. Other Name: LAF237 Drug: Metformin Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Experimental: Metformin + Placebo of vildagliptin	Drug: Placebo to vildagliptin Drug: Metformin Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago
glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1
Treatment-naïve.
Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1

Exclusion Criteria:

Pregnant or nursing (lactating) women
Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)
Previous or current participation in any vildagliptin clinical study.
History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.
Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528254

Contacts

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Show 293 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01528254 History of Changes
Other Study ID Numbers:	CLAF237A23156, 2011-003712-23
Study First Received:	February 3, 2012
Last Updated:	May 21, 2013
Health Authority:	Argentina: National Administration of Drugs, Foods and Medical Technology Brazil: National Health Surveillance Agency Bulgaria: Bulgaria Drug Agency Canada: Health Canada China: Food and Drug Administration Colombia:National Institute of Food and Drug Vigilance Costa Rica: Ministry of Health Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Guatemala: Ministry of health Hungary: National Institute of Pharmacy Hong Kong: Department of Health India: Drugs Controller General of India Italy: The Italian Medicines Agency Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency Malaysia: Ministry of Health Mexico: National Institute of Public Health, Health Secretariat Panama: Ministry of Health Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Philippines: Bureau of Food and Drugs Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control Taiwan: Center for Drug Evaluation Turkey: Ministry of Health Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:

Type 2 Diabetes Mellitus,
Vildagliptin,
Elderly Patients

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013

VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus (0)