NCT01426802

Brief Summary

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

July 1, 2011

Last Update Submit

February 23, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

metforminvildagliptinT2DM

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety and tolerability of vildagliptin 50 mg bid

    Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety.

    12 weeks

Study Arms (1)

Vildagliptin 50 bid

EXPERIMENTAL
Drug: vildagliptin

Interventions

vildagliptinDRUG

Drug 50mg vildagliptin bid

Vildagliptin 50 bid

Eligibility Criteria

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

You may qualify if:

  • Patients who sign the informed consent
  • HbA1c in the range of \> 7 to ≤10.5% at Visit 1
  • Ability to comply with all study requirements

You may not qualify if:

  • Pregnant or lactating women
  • Serious cardiovascular disorders
  • Liver/renal disease or dysfunction
  • Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
  • Laboratories values abnormalities as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigative site

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

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

July 1, 2011

First Posted

August 31, 2011

Study Start

October 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

EG(1)