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 (0431-803)(COMPLETED) - 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: sitagliptin Drug: Comparator: glimepiride Drug: open-label metformin	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 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:

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: Week 0 to Week 30 ] [ Designated as safety issue: No ]
Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcome Measures:

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
Change from baseline at Week 30 was defined as Week 30 minus Week 0.
Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
Change From Baseline in Body Weight at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
Change from baseline at Week 30 was defined as Week 30 minus Week 0.
Percent of Patients With A1C <7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
Percent of Patients With A1C <6.5% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Enrollment:	1035
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
Experimental: 1 sitagliptin	Drug: sitagliptin Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks Other Name: Januvia Drug: open-label metformin open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment. Other Name: metformin
Active Comparator: 2 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. Drug: open-label metformin open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment. Other Name: metformin

Arms

Assigned Interventions

Experimental: 1

sitagliptin

Drug: sitagliptin

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

Other Name: Januvia

Drug: open-label metformin

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Other Name: metformin

Active Comparator: 2

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.

Drug: open-label metformin

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Other Name: metformin

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

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

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00701090 History of Changes
Other Study ID Numbers:	MK-0431-803, 2008_503
Study First Received:	June 17, 2008
Results First Received:	September 13, 2010
Last Updated:	December 17, 2010
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Merck:

Type 2 Diabetes Mellitus
Non Insulin Dependent

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