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A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes

This study is currently recruiting participants.
Verified by Merck, November 2008

Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00631488
  Purpose

This study will test the effectiveness and safety of treatment with MK0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MK0893
Drug: Comparator: sitagliptin phosphate
Drug: Comparator: Metformin hydrochloride
Drug: Comparator: Placebo (Unspecified)
Phase II

MedlinePlus related topics:   Diabetes   

Drug Information available for:   Metformin    Metformin hydrochloride    Sitagliptin phosphate    Sitagliptin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:
  • The effect of treatment of MK0893 in combination with sitagliptin or with metformin compared to the combination of sitagliptin and metformin on 24-hour weighted mean glucose levels after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of MK0893 after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   126
Study Start Date:   February 2008
Estimated Study Completion Date:   January 2009
Estimated Primary Completion Date:   January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1
Arm 1: study medication/sitagliptin + Pbo
Drug: MK0893
MK0893 40mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: Placebo (Unspecified)
Matching Placebo for each arm of the trial
2
Arm 2: sitagliptin/metformin + Pbo
Drug: Comparator: sitagliptin phosphate
sitagliptin phosphate 100 mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: Metformin hydrochloride
Metformin hydrochloride 2000 mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: Placebo (Unspecified)
Matching Placebo for each arm of the trial
3
Arm 3: study medication/metformin + Pbo
Drug: MK0893
MK0893 40mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: Metformin hydrochloride
Metformin hydrochloride 2000 mg tablet qd po for the duration of the study (4 weeks)
Drug: Comparator: Placebo (Unspecified)
Matching Placebo for each arm of the trial

  Eligibility
Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

  • Patients have a history of Type 1 Diabetes Mellitus
  • Patients taking insulin or TZD (PPAR-gamma agonist)
  • Patients who have a contraindication to metformin or sitagliptin
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631488

Contacts
Contact: Toll Free Number     1-888-577-8839    

Locations
United States, California
Call for Information     Recruiting
      Walnut Creek, California, United States, 94598
United States, Florida
Call for Information     Recruiting
      Miami, Florida, United States, 33169
United States, Kentucky
Call for Information     Recruiting
      Louisville, Kentucky, United States, 40213
United States, New Jersey
Call for Information     Recruiting
      Toms River, New Jersey, United States, 08753
United States, North Carolina
Call for Information     Recruiting
      Winston-Salem, North Carolina, United States, 27103-3914
Call for Information     Recruiting
      Charlotte, North Carolina, United States, 28211
Denmark
Merck Sharp & Dohme     Recruiting
      Glostrup, Denmark, 2600
      Contact: Christina Wengel     45-43-28-77-90        
France
Laboratoires Merck Sharp & Dohme - Chibret     Recruiting
      Paris Cedex 8, France, 75114
      Contact: Jean-Marie Goehrs     33-1-4754-89-90        
Germany
Msd Sharp & Dohme Gmbh     Recruiting
      Haar, Germany, 85540
      Contact: Thomas Lang     49-89-4561-1536        
Mexico, D.F.
Merck Sharp & Dohme De Mexico, S.A. De C.V.     Recruiting
      Mexico, D.F., Mexico, 1090
      Contact: Juan Diaz     52-55-5481-9825        
Spain
Merck Sharp & Dohme De Espana, S.A.E.     Recruiting
      Madrid, Spain, 28027
      Contact: Jorge Gonzalez-Esteban     34-91-3210-728        
Sweden
Merck Sharp & Dohme (Sweden) AB     Recruiting
      Sollentuna, Sweden, 192 07
      Contact: Roger Juhlin     46-8-626-1 458        

Sponsors and Collaborators
Merck

Investigators
Study Director:     Medical Monitor     Merck    
  More Information


Responsible Party:   Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:   2007_646, MK0893-015
First Received:   February 21, 2008
Last Updated:   November 13, 2008
ClinicalTrials.gov Identifier:   NCT00631488
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008




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