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Trial record 1 of 1 for:    20456211 [PUBMED-IDS]
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An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

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ClinicalTrials.gov Identifier: NCT00094770
Recruitment Status : Completed
First Posted : October 25, 2004
Results First Posted : December 22, 2009
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: sitagliptin (MK0431) Drug: Comparator: glipizide Phase 3

Detailed Description:
The duration of treatment is 104 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitagliptin 100 mg
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Drug: sitagliptin (MK0431)
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Other Name: MK0431

Active Comparator: Glipizide
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.
Drug: Comparator: glipizide
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 Name: Glipizide




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094770


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00094770     History of Changes
Other Study ID Numbers: 0431-024
MK0431-024
2004_049
First Posted: October 25, 2004    Key Record Dates
Results First Posted: December 22, 2009
Last Update Posted: August 26, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action