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Trial record 80 of 747 for:    Area Under Curve AND meal

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

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ClinicalTrials.gov Identifier: NCT00929201
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : February 1, 2010
Last Update Posted : August 13, 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 Mellitus
Interventions Drug: Sitagliptin phosphate/metformin hydrochloride FDC
Drug: Sitagliptin phosphate
Drug: Metformin hydrochloride
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sita + Met Then Sita/Met FDC Sita/Met FDC Then Sita + Met
Hide Arm/Group Description Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2. Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Period Title: Period 1
Started 30 31
Completed 30 30
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: 7-day Washout
Started 30 30
Completed 30 30
Not Completed 0 0
Period Title: Period 2
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All randomized participants
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants
32.4
(18 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
32
  52.5%
Male
29
  47.5%
Height  
Mean (Full Range)
Unit of measure:  Centimeters
Number Analyzed 61 participants
164.9
(150.0 to 184.0)
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 61 participants
73.0
(45.9 to 102.3)
1.Primary Outcome
Title Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
Hide Description Serum samples were used to determine the AUC from time 0 to infinity for metformin.
Time Frame Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed and who had pharmacokinetic data available from at least one treatment period
Arm/Group Title Sita + Met Sita/Met FDC
Hide Arm/Group Description:
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Deviation)
Unit of Measure: μg * hr/mL
7.65  (1.39) 7.45  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita + Met, Sita/Met FDC
Comments Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets
Type of Statistical Test Non-Inferiority or Equivalence
Comments The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin [i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)].
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.97
Confidence Interval 90%
0.95 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Peak Plasma Concentration (Cmax) of Metformin
Hide Description Serum samples were used to determine the maximum concentration for metformin.
Time Frame Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed and who had pharmacokinetic data available from at least one treatment period
Arm/Group Title Sita + Met Sita/Met FDC
Hide Arm/Group Description:
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
Overall Number of Participants Analyzed 60 60
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL
929  (181) 887  (187)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita + Met, Sita/Met FDC
Comments Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets
Type of Statistical Test Non-Inferiority or Equivalence
Comments The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin [i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)].
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.95
Confidence Interval 90%
0.93 to 0.98
Estimation Comments [Not Specified]
Time Frame Up to 24 days (including 14 days after administration of study drug in the last treatment period)
Adverse Event Reporting Description All participants as treated defined as all participants who received at least one dose of study drug
 
Arm/Group Title Sita + Met Sita/Met FDC
Hide Arm/Group Description Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
All-Cause Mortality
Sita + Met Sita/Met FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sita + Met Sita/Met FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sita + Met Sita/Met FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   2/60 (3.33%)   6/61 (9.84%) 
Nervous system disorders     
Headache  1  2/60 (3.33%)  6/61 (9.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00929201     History of Changes
Other Study ID Numbers: 0431A-080
MK-0431A-080 ( Other Identifier: Merck protocol number )
2009_607 ( Other Identifier: Merck registration number )
First Submitted: June 25, 2009
First Posted: June 26, 2009
Results First Submitted: January 5, 2010
Results First Posted: February 1, 2010
Last Update Posted: August 13, 2015