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Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vildagliptin
Vildagliptin Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Blood glucose criteria must be met Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Diagnosis of type 2 diabetes for at least 8 weeks Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular complications Significant laboratory abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures

Adverse event profile after 52 weeks of treatment
Patients with HbA1c <6.5% at 12 weeks
Patients with HbA1c <6.5% at 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Coefficient of failure for HbA1c between 24 weeks and 52 weeks

Full Information

First Posted
January 12, 2005
Last Updated
May 4, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00101712
Brief Title
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Official Title
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Other Intervention Name(s)
LAF237
Intervention Type
Drug
Intervention Name(s)
Vildagliptin Placebo
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c at 52 weeks
Secondary Outcome Measure Information:
Title
Adverse event profile after 52 weeks of treatment
Title
Patients with HbA1c <6.5% at 12 weeks
Title
Patients with HbA1c <6.5% at 52 weeks
Title
Change from baseline in fasting plasma glucose at 52 weeks
Title
Coefficient of failure for HbA1c between 24 weeks and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Blood glucose criteria must be met Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Diagnosis of type 2 diabetes for at least 8 weeks Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular complications Significant laboratory abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Investigative Site
Country
Germany
Facility Name
Novartis Investigative Site
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18248490
Citation
Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
Results Reference
derived
PubMed Identifier
17925336
Citation
Mari A, Scherbaum WA, Nilsson PM, Lalanne G, Schweizer A, Dunning BE, Jauffret S, Foley JE. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008 Jan;93(1):103-9. doi: 10.1210/jc.2007-1639. Epub 2007 Oct 9.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

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