Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Novartis. Recruitment status was Active, not recruiting

First Received on January 13, 2009. Last Updated on January 5, 2010 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00821977

Purpose

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Vildagliptin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM [ Time Frame: 76 weeks ] [ Designated as safety issue: Yes ]
Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	November 2008
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vildagliptin Dose 1	Drug: Vildagliptin
Experimental: Vildagliptin Dose 2	Drug: Vildagliptin
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients at least 18 years of age at Visit 1
Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion Criteria:

Pregnant or lactating female
FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821977

Show 176 Study Locations

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00821977 History of Changes
Other Study ID Numbers:	CLAF237B2201
Study First Received:	January 13, 2009
Last Updated:	January 5, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; India: Drugs Controller General of India; Philippines: Bureau of Food and Drugs; Malaysia: Ministry of Health; Slovakia: State Institute for Drug Control; Romania: National Medicines Agency

Keywords provided by Novartis:

Type 2 Diabetes
Vildagliptin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012