NCT01582243

Brief Summary

This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2013

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

April 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

April 18, 2012

Results QC Date

September 15, 2016

Last Update Submit

September 15, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, type 2vildagliptin

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

    HbA1c analysis will be performed on a blood sample obtained by study personnel.

    Baseline, Week 24

Secondary Outcomes (5)

  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

    Baseline, week 12

  • Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24

    Baseline, week 12, week 24

  • Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24

    Baseline, week, week 24

  • Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week

    Baseline, week 24

  • The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment

    week 12, week 24

Study Arms (1)

Vildagliptin plus metformin (SPC)

EXPERIMENTAL

Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.

Drug: Vildagliptin

Interventions

VildagliptinDRUG

Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Also known as: LAF237, Galvus Met
Vildagliptin plus metformin (SPC)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients who were 20 years of age and older with diagnosis of T2DM.
  • Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
  • Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
  • Understood the nature of the study, and had signed informed consent form.

You may not qualify if:

  • Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
  • Patients with renal dysfunction defined as creatinine clearance \< 60 ml/min at Visit 1.
  • Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT \> 3 ULN at Visit 1.
  • Female patients who needed to lactate during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 20, 2012

Study Start

April 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2016

Results First Posted

November 3, 2016

Record last verified: 2016-09

Locations

TW(1)