Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00993187

Purpose

This study will assess the effect of Janumet (MK0431A) compared with the effect of glimepiride on HbA1c.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: Janumet/MK0431A (sitagliptin phosphate (+) metformin hydrochloride) Drug: Comparator: glimepiride	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in HbA1c at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose (FPG) at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: Yes ]
Number of patients with hypoglycemic events [ Time Frame: up to Week 30 ] [ Designated as safety issue: No ]
The change from baseline in body weight at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
Number of patients with HbA1c < 7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	February 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0431A	Drug: Janumet/MK0431A (sitagliptin phosphate (+) metformin hydrochloride) MK0431A (sitagliptin/metformin) up to 50/1000 mg BID for 30 weeks
2: Active Comparator Glimepiride	Drug: Comparator: glimepiride Glimepiride 1-6 mg QD for 30 Weeks

Eligibility

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

Criteria

Inclusion Criteria:

Patient Has T2DM
Patient Is Currently Not On An AHA (Off For At Least 12 Weeks) And Has A Visit 1/Screening Visit Hba1c Greater Than Or Equal To 7.0% And Less Than Or Equal To 9.5% Or Patient Is Currently On AHA Monotherapy Or Low-Dose (I.E., Less Than Or Equal To 50% Maximum Labeled Dose Of Each Agent) Oral Combination Therapy And Has A Visit 1/Screening Visit Hba1c Greater Than Or Equal To 6.5% And Less Than Or Equal To 9.0%

Exclusion Criteria:

Patient Has A History Of Type 1 Diabetes Mellitus Or A History Of Ketoacidosis
Patient Has Been On Any Investigational Or Approved GLP-1 Analogue (such as exenatide, liraglutide, ect.), any investigational or approved DDP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, ect.) or a PPAR alpha Agonist Agent (such as rosiglitazone, pioglitazone, ect.) within 12 Weeks Of Visit 1
Patient Required Insulin Within The Prior 12 Weeks
Patient has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, ect.), DPP-4 inhibitor (such as sitaliptin, vildagliptin, alogliptin, ect.), or biguanide medication (such as metformin etc.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993187

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_672, MK0431A-202
Study First Received:	October 9, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00993187 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Metformin
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