NCT00833027

Brief Summary

Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Trial Health

100
On Track

Trial Health Score

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

Enrollment
608

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 21, 2010

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

January 28, 2009

Results QC Date

August 26, 2010

Last Update Submit

April 10, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in HbA1c at Week 24

    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent

    Baseline and Week 24

Secondary Outcomes (1)

  • Change From Baseline in HbA1c at Week 12

    Baseline and Week 12

Study Arms (1)

1

EXPERIMENTAL

Sitagliptin

Drug: sitagliptin phosphate

Interventions

sitagliptin phosphateDRUG

Sitagliptin 100 mg/day - tablet for 24 weeks

Also known as: Januvia
1

Eligibility Criteria

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

You may qualify if:

  • Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 30, 2009

Study Start

March 1, 2008

Primary Completion

October 30, 2009

Study Completion

October 30, 2009

Last Updated

May 15, 2017

Results First Posted

September 21, 2010

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php