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Trial record 28 of 1422 for:    Area Under Curve AND tablet

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

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ClinicalTrials.gov Identifier: NCT01093794
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : June 27, 2011
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet
Enrollment 28
Recruitment Details 28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.
Pre-assignment Details  
Arm/Group Title 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC
Hide Arm/Group Description

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • Co-administration of 50 mg sitagliptin and 500 mg metformin
  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 850 mg metformin

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • Co-administration of 50 mg sitagliptin and 500mg metformin
  • sitagliptin/metformin 50 mg/850 mg FDC tablet

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 500mg metformin

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 500 mg metformin
  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • sitagliptin/metformin 50 mg/500 mg FDC tablet
Period Title: Treatment Period 1
Started 7 7 7 7
Completed 7 7 7 7
Not Completed 0 0 0 0
Period Title: Treatment Period 2
Started 7 7 6 [1] 7
Completed 7 7 6 7
Not Completed 0 0 0 0
[1]
After period 1, one participant was discontinued by the investigator due to a protocol deviation.
Period Title: Treatment Period 3
Started 7 7 6 7
Completed 7 7 6 7
Not Completed 0 0 0 0
Period Title: Treatment Period 4
Started 7 7 6 7
Completed 7 7 6 7
Not Completed 0 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
28.6  (5.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
0
   0.0%
Male
28
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 28 participants
28
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 28 participants
22  (1.22)
1.Primary Outcome
Title Area Under the Curve (AUC(0-t)) for Sitagliptin
Hide Description AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Time Frame baseline through 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.
Arm/Group Title Sit 50 mg + Met 500 mg SitMet 50mg/500mg FDC Sit 50 mg + Met 850 mg SitMet 50mg/850mg FDC
Hide Arm/Group Description:
Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
Overall Number of Participants Analyzed 27 27 27 27
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
sitagliptin 50 mg 1570  (217.40) 1590  (186.58) 1520  (228.83) 1600  (195.05)
metformin 500 mg 8350  (1881.70) 8750  (1920.45) NA [1]   (NA) NA [1]   (NA)
metformin 850 mg NA [2]   (NA) NA [2]   (NA) 11800  (2849.36) 13100  (2987.28)
[1]
Metformin 500 mg was not administered during this treatment.
[2]
Metformin 850 mg was not administered during this treatment.
2.Primary Outcome
Title Cmax for Sitagliptin and Metformin
Hide Description Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Time Frame baseline through 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.
Arm/Group Title Sit 50 mg + Met 500 mg SitMet 50mg/500mg FDC Sit 50 mg + Met 850 mg SitMet 50mg/850mg FDC
Hide Arm/Group Description:
Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
Overall Number of Participants Analyzed 27 27 27 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
sitagliptin 50 mg 189  (37.76) 182  (38.71) 187  (40.31) 194  (32.67)
Metformin 500 mg 1210  (323.83) 1310  (383.57) NA [1]   (NA) NA [1]   (NA)
Metformin 850 mg NA [2]   (NA) NA [2]   (NA) 1790  (488.51) 1970  (482.69)
[1]
Metformin 500 mg was not administered during this treatment.
[2]
Metformin 850 mg was not administered during this treatment.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sit 50 mg + Met 500 mg Sit/Met 50 mg/500 mg FDC Sit 50 mg + Met 850 mg Sit/Met 50 mg/850 mg FDC
Hide Arm/Group Description AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin. AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet. AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin. AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
All-Cause Mortality
Sit 50 mg + Met 500 mg Sit/Met 50 mg/500 mg FDC Sit 50 mg + Met 850 mg Sit/Met 50 mg/850 mg FDC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sit 50 mg + Met 500 mg Sit/Met 50 mg/500 mg FDC Sit 50 mg + Met 850 mg Sit/Met 50 mg/850 mg FDC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sit 50 mg + Met 500 mg Sit/Met 50 mg/500 mg FDC Sit 50 mg + Met 850 mg Sit/Met 50 mg/850 mg FDC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/28 (14.29%)   3/28 (10.71%)   4/28 (14.29%)   2/28 (7.14%) 
Blood and lymphatic system disorders         
Leucocytosis 1 [1]  0/28 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Ear and labyrinth disorders         
Vertigo  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1/28 (3.57%)  1/28 (3.57%)  1/28 (3.57%)  1/28 (3.57%) 
Diarrhea  2/28 (7.14%)  1/28 (3.57%)  1/28 (3.57%)  0/28 (0.00%) 
Nausea  1/28 (3.57%)  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
Flatulence  0/28 (0.00%)  0/28 (0.00%)  2/28 (7.14%)  0/28 (0.00%) 
General disorders         
Fever  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%)  0/28 (0.00%) 
Chest pain  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
Nervous system disorders         
Headache  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA (14.0)
[1]
Laboratory finding
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01093794     History of Changes
Other Study ID Numbers: 0431A-122
2010_518
First Submitted: March 19, 2010
First Posted: March 26, 2010
Results First Submitted: June 3, 2011
Results First Posted: June 27, 2011
Last Update Posted: July 28, 2015