Back to resultsEarly add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Primary Purpose
Type-2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
LAF237 (vildagliptin)
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type-2 Diabetes Mellitus focused on measuring type-2 diabetes mellitus, inadequately controlled Metformin
Eligibility Criteria
Inclusion Criteria:
- Male or Female in age ≥18 at Visit 1
- Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
- HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
- With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin
Key Exclusion Criteria:
- Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
- Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
- Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
- Pregnant women or breastfeeding women at the time of enrolment
- Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LAF237 (vildagliptin) 50mg once daily (QD)
LAF237 (vildagliptin) 50mg twice daily (BID)
Arm Description
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Outcomes
Primary Outcome Measures
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c
Secondary Outcome Measures
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.
Percentage of Patients Achieving Good Glycemic Control
Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.
Percentage of Overall Drug Compliance in 12 Months
The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]
Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability
This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.
Full Information
NCT ID
NCT01766778
First Posted
January 9, 2013
Last Updated
April 7, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01766778
Brief Title
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Official Title
A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 13, 2013 (Actual)
Primary Completion Date
October 22, 2015 (Actual)
Study Completion Date
October 22, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-2 Diabetes Mellitus
Keywords
type-2 diabetes mellitus, inadequately controlled Metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAF237 (vildagliptin) 50mg once daily (QD)
Arm Type
Active Comparator
Arm Description
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
Arm Title
LAF237 (vildagliptin) 50mg twice daily (BID)
Arm Type
Active Comparator
Arm Description
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Intervention Type
Drug
Intervention Name(s)
LAF237 (vildagliptin)
Other Intervention Name(s)
LAF237
Intervention Description
Vildagliptin 50mg capsule
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin maximum tolerance dose
Primary Outcome Measure Information:
Title
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
Description
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c
Time Frame
Baseline, Month 12 (weeK 52)
Secondary Outcome Measure Information:
Title
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Description
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.
Time Frame
Baseline, Month 3, 6, 9 and 12
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Description
Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.
Time Frame
Baseline, Month 3, 6, 9 and 12
Title
Percentage of Patients Achieving Good Glycemic Control
Description
Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.
Time Frame
Month 3, 6, 9, 12
Title
Percentage of Overall Drug Compliance in 12 Months
Description
The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]
Time Frame
Month 12
Title
Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability
Description
This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female in age ≥18 at Visit 1
Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin
Key Exclusion Criteria:
Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1
Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
Pregnant women or breastfeeding women at the time of enrolment
Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
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
Hong Kong SAR
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
HongKong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Tuen Mun
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
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