NCT00686634

Brief Summary

This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

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

Timeline
Completed

Started Jan 2008

Typical duration 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

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

November 26, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

May 27, 2008

Results QC Date

February 24, 2012

Last Update Submit

November 25, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

sitagliptintype 2 diabetescombination therapy

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c) Change From Baseline

    Baseline, 4 months

Secondary Outcomes (3)

  • Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months

    4 months

  • Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year

    1 year

  • Number of Adverse Events

    1 year

Study Arms (1)

1

EXPERIMENTAL

Sitagliptin 100 mg once daily

Drug: Sitagliptin

Interventions

SitagliptinDRUG

Sitagliptin 100 mg by mouth once daily

Also known as: Trade name: Januvia
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 18-75
  • Type 2 diabetes
  • At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) \>7.0%)
  • Able to comply with all scheduled visits and requirements of the protocol

You may not qualify if:

  • Any contraindications to the use of metformin or a sulfonylurea agent
  • Extreme hyperglycemia or symptoms of polyuria or polydipsia
  • Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
  • History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
  • Episodes of symptomatic hypoglycemia averaging greater than once per day
  • Estimated glomerular filtration rate (eGFR) \< 60 mL/min
  • Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
  • History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
  • Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
  • Current pregnancy or lactation.
  • Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
  • Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
  • Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Publications (1)

  • Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.

    PMID: 21550951DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Stanley H. Hsia, MD
Organization
Charles R. Drew University of Medicine and Science
stanleyhsia@cdrewu.edu
323-357-3633

Study Officials

  • Stanley Hsia, MD

    Charles Drew University of Medicine and Science

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 26, 2014

Results First Posted

November 26, 2014

Record last verified: 2014-11

Locations

US(1)