Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus (0431A-202) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00993187

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Non-insulin-dependent	Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: glimepiride	Phase III

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

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

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:	May 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0431A	Drug: sitagliptin phosphate (+) metformin hydrochloride MK0431A (sitagliptin/metformin) up to 50/1000 mg BID for 30 weeks Other Name: Janumet
Active Comparator: 2 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 sitagliptin, vildagliptin, alogliptin, ect.), or biguanide medication (such as metformin etc.)
Patient has uncontrolled hypertension
Patient has Cirrhosis or active live disease
Patient has severe cardiac conditions
Patient is obese
Patient has HIV

Contacts and Locations

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

Locations

Korea, Republic of
MSD Korea Ltd.	Recruiting
Seoul, Korea, Republic of, 121-705
Contact: Yong Soo Kim 82263630241

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00993187 History of Changes
Other Study ID Numbers:	2009_672, MK0431A-202
Study First Received:	October 9, 2009
Last Updated:	December 2, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012