A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01582308
First received: April 19, 2012
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin 100 mg
Drug: Saxagliptin 5 mg
Drug: Vildagliptin 50 mg
Drug: Vildagliptin 50 mg BID
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Enrolled Participants No text entered.

Baseline Measures
    All Enrolled Participants  
Number of Participants  
[units: participants]
  22  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     0  
Gender  
[units: Participants]
 
Female     12  
Male     10  



  Outcome Measures
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1.  Primary:   Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough   [ Time Frame: 24 hours following the final morning dose on Day 5 ]

2.  Secondary:   Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)   [ Time Frame: Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5 ]

3.  Secondary:   Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID   [ Time Frame: Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5 ]

4.  Secondary:   Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)   [ Time Frame: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5 ]

5.  Secondary:   Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)   [ Time Frame: Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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