Clinical trial NCT01766778: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type-2 Diabetes Mellitus
Keywords: type-2 diabetes mellitus, inadequately controlled Metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or Female in age ≥18 at Visit 1
2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
4. 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:

1. 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
2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
3. Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
4. Pregnant women or breastfeeding women at the time of enrolment
5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment

Primary outcomes:
measure: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
timeFrame: Baseline, Month 12 (weeK 52)
Secondary outcomes:
measure: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
timeFrame: Baseline, Month 3, 6, 9 and 12
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
timeFrame: Baseline, Month 3, 6, 9 and 12
measure: Percentage of Patients Achieving Good Glycemic Control
timeFrame: Month 3, 6, 9, 12
measure: Percentage of Overall Drug Compliance in 12 Months
timeFrame: Month 12
measure: Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability
timeFrame: Month 12
Other outcomes:
Locations:
city: Hong Kong SAR
country: Hong Kong
facility: Novartis Investigative Site
city: HongKong
country: Hong Kong
facility: Novartis Investigative Site
city: Tuen Mun
country: Hong Kong
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: