Study of Sitagliptin in Older Type 2 Diabetics - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00305604

Purpose

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Comparator: sitagliptin phosphate Drug: Comparator: Placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin phosphate Sitagliptin Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus

Further study details as provided by Merck:

Primary Outcome Measures:

A1C [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

(1) Overall safety and tolerability; (2) FPG at 24 weeks; (3) 2-hr PPG as determined by 3-Point MTT at 24 weeks; (4) rapidity of onset of action as determined by home glucose monitoring after 1 week; (5) % of patients achieving A1C < 7.0 % at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	206
Study Start Date:	March 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator sitagliptin	Drug: Comparator: sitagliptin phosphate Once daily administration of sitagliptin 100 mg tablet(or 50 mg based on creatinine clearance). For up to a 32-wk treatment period.
2: Placebo Comparator Placebo	Drug: Comparator: Placebo sitagliptin matching placebo for up to a 32-wk treatment period.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

Patients with type 1 diabetes
History of ketoacidosis or requires insulin use
ALT/AST >2.5 X ULN, TG >600mg/dL, Creatinine Clearance <35mL/min
Fasting plasma glucose consistently >260mg/dL
Poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305604

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_003, MK0431-047
Study First Received:	March 20, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00305604
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009