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TerminatedNCT00543959Updated Jun 23, 2015

Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

A Phase 2 interventional study of MK0533 and Comparator: Placebo (unspecified) in Diabetes Mellitus Type 2, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-23.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Why this study was terminated
This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic \& body fluid benefits vs. the comparitor
Phase
Phase 2
Study type
Interventional
Enrollment
346
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 346 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
  • Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened

Exclusion criteria

Exclusion Criteria:

  • Patients taking any medicines that affect body fluid level such as a diuretic or water pill
  • Patients taking niacin or other certain medications
  • Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
  • Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
346 participants (actual)

Study arms

  • Experimental
    Part1 - Arm 1

    Part1: Arm 1: drug

    Drug: MK0533

  • Placebo comparator
    Part1 - Arm 2

    Part1 - Arm 2: Pbo comparator

    Drug: Comparator: Placebo (unspecified)

  • Placebo comparator
    Part 2 - Arm 1

    Part 2 - Arm 1: Pbo

    Drug: Comparator: Placebo (unspecified)

  • Experimental
    Part 2 - Arm 2

    Part 2- Arm 2: drug 5mg

    Drug: MK0533

  • Experimental
    Part 2 - Arm 3

    Part 2 - Arm 3: drug 15mg

    Drug: MK0533

  • Experimental
    Part 2 - Arm 4

    Part 2 - Arm 4: drug 30mg

    Drug: MK0533

  • Active comparator
    Part 2 - Arm 5

    Part 2 - Arm 5: active comparator

    Drug: Comparator: pioglitazone

Interventions

  • DrugMK0533

    Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

  • DrugComparator: Placebo (unspecified)

    MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.

  • DrugComparator: pioglitazone

    pioglitazone 45mg. Study period is a total of 24 wks.

06

What researchers measure

Primary outcomes

  1. Body fluid gain from baseline after 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Fasting plasma glucose after 12 weeks

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00543959
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 15, 2007
Start date
Jun 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Jun 23, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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