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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

vildagliptin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, vildagliptin, metformin combination

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Novartis Investigative Site

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in fasting plasma glucose

Adverse event profiles including gastrointestinal tolerability and hypoglycemia

Responder rates

Change from baseline in insulin and proinsulin in a subgroup of patients

Change in systolic and diastolic blood pressure

Full Information

NCT ID

NCT00494884

First Posted

June 29, 2007

Last Updated

February 23, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00494884

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin, metformin combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose

Time Frame

24 weeks

Title

Adverse event profiles including gastrointestinal tolerability and hypoglycemia

Time Frame

24 weeks

Title

Responder rates

Time Frame

24 weeks

Title

Change from baseline in insulin and proinsulin in a subgroup of patients

Time Frame

24 weeks

Title

Change in systolic and diastolic blood pressure

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

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 Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. W. E. Schmidt

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Bochum

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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