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Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vildagliptin
Metformin
Vildagliptin + Metformin
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, metformin, hemoglobin A1c

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
  • Diagnosis of T2DM for at least 4 weeks prior to study entry
  • Age 18 - 78 years inclusive
  • Body mass index (BMI) of 22 - 40 kg/m2
  • HbA1c: 7.5 - 11% inclusive
  • FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria

  • Pregnant or lactating female
  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Vildagliptin + Metformin Dose 1

Vildagliptin + Metformin Dose 2

Vildagliptin

Metformin

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in fasting plasma glucose
Percent of patients with endpoint HbA1c <7%
Percent of patients with reduction in HbA1c >/=0.7%
Adverse event profile after treatment
Change from baseline in body weight

Full Information

First Posted
September 26, 2006
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00382096
Brief Title
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Official Title
A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 3, 2008 (Actual)
Study Completion Date
June 3, 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

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, hemoglobin A1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin + Metformin Dose 1
Arm Type
Experimental
Arm Title
Vildagliptin + Metformin Dose 2
Arm Type
Experimental
Arm Title
Vildagliptin
Arm Type
Active Comparator
Arm Title
Metformin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Vildagliptin + Metformin
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
At week 24
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose
Time Frame
At week 24
Title
Percent of patients with endpoint HbA1c <7%
Time Frame
At week 24
Title
Percent of patients with reduction in HbA1c >/=0.7%
Time Frame
At week 24
Title
Adverse event profile after treatment
Time Frame
At week 24
Title
Change from baseline in body weight
Time Frame
At week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes Diagnosis of T2DM for at least 4 weeks prior to study entry Age 18 - 78 years inclusive Body mass index (BMI) of 22 - 40 kg/m2 HbA1c: 7.5 - 11% inclusive FPG <270 mg/dL (15 mmol/L) Exclusion Criteria Pregnant or lactating female A history of type 1 diabetes Evidence of significant diabetic complications Other protocol-defined inclusion/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 Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
City
Multiple Locations
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2650
Description
Clinical Trial Results for CLMF237A2302 at Novartis Clinical Trials.com

Learn more about this trial

Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

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