Study of Sitagliptin in Older Type 2 Diabetics - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 20, 2006

Last Updated Date

March 19, 2009

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00305604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change From Baseline in 2-Hour PPG (Post-Prandial Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Overall safety and tolerability, fasting plasma glucose, and 2-hr post prandial glucose at 24 weeks; rapidity of onset of action as determined by home glucose monitoring after 1 week of therapy.

Descriptive Information

Brief Title ^†

Study of Sitagliptin in Older Type 2 Diabetics

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Type 2 Diabetes

Intervention ^†

Drug: Comparator: sitagliptin phosphate
Drug: Comparator: Placebo

Study Arms / Comparison Groups

Active Comparator: sitagliptin
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

190

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00305604

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0431-047

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.