NCT01766778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2013

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

May 13, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

January 9, 2013

Results QC Date

February 23, 2017

Last Update Submit

April 7, 2017

Conditions

Type-2 Diabetes Mellitus

Keywords

type-2 diabetes mellitus, inadequately controlled Metformin

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, Month 12 (weeK 52)

Secondary Outcomes (5)

  • Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)

    Baseline, Month 3, 6, 9 and 12

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)

    Baseline, Month 3, 6, 9 and 12

  • Percentage of Patients Achieving Good Glycemic Control

    Month 3, 6, 9, 12

  • Percentage of Overall Drug Compliance in 12 Months

    Month 12

  • Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability

    Month 12

Study Arms (2)

LAF237 (vildagliptin) 50mg once daily (QD)

ACTIVE COMPARATOR

Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin

Drug: LAF237 (vildagliptin)Drug: Metformin

LAF237 (vildagliptin) 50mg twice daily (BID)

ACTIVE COMPARATOR

Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin

Drug: LAF237 (vildagliptin)Drug: Metformin

Interventions

LAF237 (vildagliptin)DRUG

Vildagliptin 50mg capsule

Also known as: LAF237
LAF237 (vildagliptin) 50mg once daily (QD)LAF237 (vildagliptin) 50mg twice daily (BID)
MetforminDRUG

Metformin maximum tolerance dose

LAF237 (vildagliptin) 50mg once daily (QD)LAF237 (vildagliptin) 50mg twice daily (BID)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Tuenmen, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Hong Kong SAR, Hong Kong

Location

MeSH Terms

Interventions

1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidineVildagliptinMetformin

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
trialandresults.registries@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 11, 2013

Study Start

May 13, 2013

Primary Completion

October 22, 2015

Study Completion

October 22, 2015

Last Updated

May 15, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-04

Locations

HK(4)