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A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)

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ClinicalTrials.gov Identifier: NCT00792935
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : October 3, 2012
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: MK-0941
Drug: Glimepiride
Drug: Metformin
Enrollment 143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-0941 Glimepiride
Hide Arm/Group Description Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period. Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
Period Title: Overall Study
Started 72 71
Completed 68 68
Not Completed 4 3
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             0             1
Protocol Violation             2             0
Withdrawal by Subject             0             1
Arm/Group Title MK-0941 Glimepiride Total
Hide Arm/Group Description Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period. Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period. Total of all reporting groups
Overall Number of Baseline Participants 72 71 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 71 participants 143 participants
54.8  (9.5) 55.2  (9.8) 55  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 71 participants 143 participants
Female
29
  40.3%
26
  36.6%
55
  38.5%
Male
43
  59.7%
45
  63.4%
88
  61.5%
Mean 24-Hour Weighted Mean Glucose at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 72 participants 71 participants 143 participants
178.8  (33.9) 184.4  (38.4) 181.6  (36.2)
[1]
Measure Description: Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
1.Primary Outcome
Title Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
Hide Description Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).
Arm/Group Title MK-0941 Glimepiride
Hide Arm/Group Description:
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
Overall Number of Participants Analyzed 72 71
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-43.4
(-50.0 to -36.8)
-44.2
(-50.9 to -37.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0941, Glimepiride
Comments Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments [Not Specified]
Method Constrained longitudinal analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-7.9 to 9.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Hide Description

Hypoglycemic episodes are defined as either a fingerstick glucose

measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia.

Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.
Arm/Group Title MK-0941 Glimepiride
Hide Arm/Group Description:
Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
Overall Number of Participants Analyzed 72 71
Measure Type: Number
Unit of Measure: participants
32 37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-0941, Glimepiride
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Miettinen & Nurminen method.
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportions
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-23.6 to 8.7
Estimation Comments The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.
Time Frame 14 weeks
Adverse Event Reporting Description All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).
 
Arm/Group Title MK-0941 Glimepiride
Hide Arm/Group Description All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941. All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
All-Cause Mortality
MK-0941 Glimepiride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
MK-0941 Glimepiride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/72 (1.39%)      1/71 (1.41%)    
Injury, poisoning and procedural complications     
Comminuted fracture  1  0/72 (0.00%)  0 1/71 (1.41%)  1
Investigations     
Blood creatine phosphokinase increased  1  1/72 (1.39%)  1 0/71 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0941 Glimepiride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/72 (43.06%)      25/71 (35.21%)    
Gastrointestinal disorders     
Diarrhoea  1  5/72 (6.94%)  5 1/71 (1.41%)  1
Infections and infestations     
Nasopharyngitis  1  0/72 (0.00%)  0 4/71 (5.63%)  4
Metabolism and nutrition disorders     
Hypoglycaemia  1  28/72 (38.89%)  89 23/71 (32.39%)  78
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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. Any information identified by the sponsor as confidential must be deleted prior to submission.
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: NCT00792935    
Other Study ID Numbers: 0941-017
2008_589
CTRI/2009/091/000154 ( Registry Identifier: CTRI )
First Submitted: November 14, 2008
First Posted: November 18, 2008
Results First Submitted: June 28, 2012
Results First Posted: October 3, 2012
Last Update Posted: December 17, 2015