NCT00481663

Brief Summary

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
555

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2003

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

August 19, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

June 1, 2007

Last Update Submit

March 31, 2017

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (9)

  • Change from Baseline in HbA1C at Week 12

    Baseline and Week 12

  • Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14

    Up to Week 14

  • Number of Participants Who Experienced One or More AE up to Week 54

    Up to Week 54

  • Number of Participants Who Experienced One or More AE up to Week 108

    Up to Week 108

  • Number of Participants Who Experienced One or More AE up to Week 160

    Up to Week 160

  • Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12

    Up to Week 12

  • Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52

    Up to Week 52

  • Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106

    Up to Week 106

  • Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158

    Up to Week 158

Secondary Outcomes (14)

  • Change from Baseline in HbA1C at Week 52

    Baseline and Week 52

  • Change from Baseline in HbA1C at Week 106

    Baseline and Week 106

  • Change from Baseline in HbA1C at Week 158

    Baseline and Week 158

  • Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Baseline and Week 12

  • Change from Baseline in FPG at Week 52

    Baseline and Week 52

  • +9 more secondary outcomes

Study Arms (5)

Sitagliptin 25 mg once daily

EXPERIMENTAL

Sitaglipin (MK-0431), 25 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Drug: SitagliptinDrug: Rescue

Sitagliptin 50 mg once daily

EXPERIMENTAL

Sitagliptin, 50 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Drug: SitagliptinDrug: Rescue

Sitaglipin 100 mg once daily

EXPERIMENTAL

Sitagliptin, 100 mg, once daily for 158 weeks, orally

Drug: SitagliptinDrug: Rescue

Sitagliptin 50 mg twice daily

EXPERIMENTAL

Sitagliptin 50 mg, twice daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods.

Drug: SitagliptinDrug: Rescue

Placebo to Sitagliptin → Metformin

PLACEBO COMPARATOR

Placebo to Sitagliptin, once daily, orally for 12 weeks. Participants randomized to the placebo treatment group during the base study were reallocated to treatment with metformin 850 mg twice daily (b.i.d., initiated with 850 mg q.d. for 4 weeks then force titrated to 850 mg b.i.d.) during either the first or initiation of the second extensions study periods.

Drug: Placebo to sitagliptinDrug: MetforminDrug: Rescue

Interventions

SitagliptinDRUG
Sitaglipin 100 mg once dailySitagliptin 25 mg once dailySitagliptin 50 mg once dailySitagliptin 50 mg twice daily
Placebo to sitagliptinDRUG
Placebo to Sitagliptin → Metformin
MetforminDRUG
Placebo to Sitagliptin → Metformin
RescueDRUG

Patients whose FPG \>240 mg/dL from Week 16 or HbA1C \>8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently \>240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C \>8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C \>7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.

Placebo to Sitagliptin → MetforminSitaglipin 100 mg once dailySitagliptin 25 mg once dailySitagliptin 50 mg once dailySitagliptin 50 mg twice daily

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and non-pregnant women
  • Fasting plasma glucose \>= 130 mg/dL
  • HbA1c \>=6.5% and \>10.0%

You may not qualify if:

  • You have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medication
  • You have had surgery within 30 days
  • You hvae hepatitis B or C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hanefeld M, Herman GA, Wu M, Mickel C, Sanchez M, Stein PP; Sitagliptin Study 014 Investigators. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr Med Res Opin. 2007 Jun;23(6):1329-39. doi: 10.1185/030079907X188152. Epub 2007 Apr 30.

    PMID: 17559733BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
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 1, 2007

First Posted

June 4, 2007

Study Start

August 19, 2003

Primary Completion

July 21, 2004

Study Completion

May 14, 2006

Last Updated

April 4, 2017

Record last verified: 2017-03