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
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
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
NCT ID
NCT00382096
First Posted
September 26, 2006
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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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