NCT00337610

Brief Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

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

June 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 27, 2010

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

June 14, 2006

Results QC Date

September 24, 2009

Last Update Submit

May 11, 2016

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in A1C at Week 18

    A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

    Baseline and Week 18

Secondary Outcomes (3)

  • Change From Baseline in FPG at Week 18

    Baseline and Week 18

  • Change From Baseline in 2 Hr-PMG at Week 18

    Baseline and Week 18

  • Change From Baseline in A1C at Week 30

    Baseline and Week 30

Study Arms (2)

sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day

EXPERIMENTAL
Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day

PLACEBO COMPARATOR
Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

Interventions

sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUG

Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

Also known as: Januvia
sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day
comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayDRUG

Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has type 2 diabetes mellitus
  • Males
  • Females who are highly unlikely to become pregnant
  • Patients poorly controlled while taking one or two oral antidiabetic medications

You may not qualify if:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient required insulin therapy within the prior 8 weeks
  • Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50. doi: 10.1185/030079908x260925.

    PMID: 18194595BACKGROUND

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
Executive Vice President, Clinical and Quantitative Sciences
Organization
Merck Sharp & Dohme Corp
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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

August 1, 2007

Last Updated

May 12, 2016

Results First Posted

May 27, 2010

Record last verified: 2016-05