An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00094770

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: sitagliptin (MK0431) Drug: Comparator: glipizide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
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:

Change From Baseline in HbA1c at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: No ]
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
Change From Baseline in Body Weight at Week 104 [ Time Frame: Baseline and Week 104 ] [ Designated as safety issue: Yes ]
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Hypoglycemic Events at Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
Hypoglycemic Events at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
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.
Number of Participants With Serious CAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
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.
Number of Participants With Drug-related CAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
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.
Number of Participants With Serious LAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
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.
Number of Participants With Drug-related LAEs at Week 104 [ Time Frame: Baseline to Week 104 ] [ Designated as safety issue: Yes ]
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.

Enrollment:	1172
Study Start Date:	September 2004
Study Completion Date:	May 2007
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

The duration of treatment is 104 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094770

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. Epub 2011 Apr 8.

Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00094770 History of Changes
Other Study ID Numbers:	2004_049, MK0431-024
Study First Received:	October 22, 2004
Results First Received:	September 24, 2009
Last Updated:	April 7, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Glipizide

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012