A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin. - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00701090

Purpose

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus, Non Insulin Dependent. Diabetes Mellitus, Non-Insulin-Dependent	Drug: Comparator: sitagliptin phosphate Drug: Comparator: glimepiride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Sitagliptin Sitagliptin phosphate Metformin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the change from baseline in HbA1c levels of sitagliptin compared with glimepiride. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the effect of the addition of sitagliptin compared with glimepiride on: (1) Change from baseline fasting plasma glucose (2) number of hypoglycemic episodes (3) Change from baseline in body weight. (4) Proportion of patients achieving at goal HbA1c [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Enrollment:	1050
Study Start Date:	May 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental sitagliptin	Drug: Comparator: sitagliptin phosphate 100 mg sitagliptin per day; Duration of Treatment: 30 weeks
2: Active Comparator glimepiride	Drug: Comparator: glimepiride glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Diagnosed with type 2 diabetes
On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

History of type 1 diabetes
Pregnant
HIV positive
On a weight loss program or medication
Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701090

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional 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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_503, MK0431-803
Study First Received:	June 17, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00701090 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Merck:

Type 2 Diabetes Mellitus
Non Insulin Dependent

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions

Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010