AzTrials
AzTrials

Type II Diabetes MellitusPhase 2NCT00481663

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

A Phase 2 study testing Sitagliptin, Metformin and Rescue in people with Type II Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
Sitagliptin, Metformin and Rescue
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
555 participants
Where
No sites listed yet
Study dates
19 Aug 2003to 14 May 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of Sitaglipin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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).

Being tested
Sitagliptin, Placebo to sitagliptin, Metformin, Rescue
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SitagliptinDrug

  • Placebo to sitagliptinDrug

  • MetforminDrug

  • 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.

Study groups in NCT00481663
Study groupRoleWhat they receive
Sitagliptin 25 mg once dailyExperimentalSitaglipin (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.
Receives: Drug: Sitagliptin; Drug: Rescue
Sitagliptin 50 mg once dailyExperimentalSitagliptin, 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.
Receives: Drug: Sitagliptin; Drug: Rescue
Sitaglipin 100 mg once dailyExperimentalSitagliptin, 100 mg, once daily for 158 weeks, orally
Receives: Drug: Sitagliptin; Drug: Rescue
Sitagliptin 50 mg twice dailyExperimentalSitagliptin 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.
Receives: Drug: Sitagliptin; Drug: Rescue
Placebo to Sitagliptin → MetforminPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo to sitagliptin; Drug: Metformin; Drug: Rescue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in HbA1C at Week 12

    Measured: Baseline and Week 12

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

    Measured: Up to Week 14

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

    Measured: Up to Week 54

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

    Measured: Up to Week 108

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

    Measured: Up to Week 160

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

    Measured: Up to Week 12

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

    Measured: Up to Week 52

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

    Measured: Up to Week 106

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

    Measured: Up to Week 158

Secondary outcomes (14)

  1. Change from Baseline in HbA1C at Week 52

    Measured: Baseline and Week 52

  2. Change from Baseline in HbA1C at Week 106

    Measured: Baseline and Week 106

  3. Change from Baseline in HbA1C at Week 158

    Measured: Baseline and Week 158

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

    Measured: Baseline and Week 12

  5. Change from Baseline in FPG at Week 52

    Measured: Baseline and Week 52

  6. Change from Baseline in FPG at Week 106

    Measured: Baseline and Week 106

  7. Change from Baseline in FPG at Week 158

    Measured: Baseline and Week 158

  8. Change from Baseline in Body Weight at Week 12

    Measured: Baseline and Week 12

  9. Change from Baseline in Body Weight at Week 52

    Measured: Baseline and Week 52

  10. Change from Baseline in Body Weight at Week 106

    Measured: Baseline and Week 106

  11. Change from Baseline in Body Weight at Week 158

    Measured: Baseline and Week 158

  12. Change From Baseline in Serum Fructosamine at Week 12

    Measured: Baseline and Week 12

  13. Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12

    Measured: Baseline and Week 12

  14. Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52

    Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2007 (estimated)
  2. Study start19 Aug 2003
  3. Primary completion21 Jul 2004
  4. Study completion14 May 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
555 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481663
Sponsor's protocol ID
0431-014
Other IDs
2007_570
Status last verified
Mar 2017
First submitted
1 Jun 2007
Last updated
4 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17559733

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sitagliptin, Metformin and Rescue in people with Type II Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in HbA1C at Week 12 (time frame: Baseline and Week 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00481663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in