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

February 23, 2017 updated by: Novartis

A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Drug: vildagliptin

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Bochum, Germany
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c Time Frame: 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in fasting plasma glucose Time Frame: 24 weeks	24 weeks
Adverse event profiles including gastrointestinal tolerability and hypoglycemia Time Frame: 24 weeks	24 weeks
Responder rates Time Frame: 24 weeks	24 weeks
Change from baseline in insulin and proinsulin in a subgroup of patients Time Frame: 24 weeks	24 weeks
Change in systolic and diastolic blood pressure Time Frame: 24 weeks	24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

Study Director: Prof. Dr. W. E. Schmidt, Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria