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Completed

NCT Number: NCT00094770

An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 104 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Treatment and study plan

Sitagliptin (MK0431)

Drug

Sitagliptin 100 mg oral tablets of sitagliptin once daily.

Other names: MK0431

Comparator: glipizide

Drug

Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

Other names: Glipizide

Primary outcomes

  1. Change From Baseline in HbA1c at Week 52

    Time frame: Baseline and Week 52

    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.

Secondary outcomes

  1. Change From Baseline in HbA1c at Week 104

    Time frame: Baseline and Week 104

    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.

  2. Change From Baseline in Body Weight at Week 52

    Time frame: Baseline and Week 52

    Change from baseline at Week 52 is defined as Week 52 minus Week 0.

  3. Change From Baseline in Body Weight at Week 104

    Time frame: Baseline and Week 104

    Change from baseline at Week 104 is defined as Week 104 minus Week 0.

  4. Hypoglycemic Events at Week 52

    Time frame: Baseline to Week 52

    Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.

  5. Hypoglycemic Events at Week 104

    Time frame: Baseline to Week 104

    Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.

  6. Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104

    Time frame: Baseline to Week 104

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

  7. Number of Participants With Serious CAEs at Week 104

    Time frame: Baseline to Week 104

    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.

  8. Number of Participants With Drug-related CAEs at Week 104

    Time frame: Baseline to Week 104

    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.

  9. Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104

    Time frame: Baseline to Week 104

    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.

  10. Number of Participants With Serious LAEs at Week 104

    Time frame: Baseline to Week 104

    Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.

  11. Number of Participants With Drug-related LAEs at Week 104

    Time frame: Baseline to Week 104

    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Oct 25, 2004
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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