Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

NCT ID: NCT00494884

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-07-31

Brief Summary

This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

vildagliptin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male, non-fertile female or female of childbearing potential using a medically approved birth control method
• Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
• Agreement to maintain the same dose of metformin throughout the study
• Age in the range of 18-85 years inclusive.
• HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
• Agreement to maintain prior diet and exercise habits during the full course of the study
• Ability to comply with all study requirements and signed informed consent to participate in the study.

Exclusion Criteria

• Pregnant or lactating female

A history of:

• type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
• acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.

Any of the following significant laboratory abnormalities:

• ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
• Direct bilirubin greater than the upper limit of the normal range at visit 1.
• Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
• Clinically significant TSH values outside of normal range at visit 1.
• Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. W. E. Schmidt

Role: STUDY_DIRECTOR

Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309

Locations

Novartis Investigative Site

Bochum, , Germany

Countries

Germany

Other Identifiers

CLAF237ADE02

Identifier Type: -

Identifier Source: org_study_id