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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094770
• Other study ID #: 0431-024
• Secondary ID: MK0431-0242004_0
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2004
• Last updated: August 25, 2016
• Start date: September 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

The duration of treatment is 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1172
• Est. completion date: May 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• sitagliptin (MK0431)
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

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