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Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)

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ClinicalTrials.gov Identifier: NCT01177384
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : April 28, 2014
Last Update Posted : August 16, 2018
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: Sitagliptin phosphate
Drug: Comparator: Placebo
Drug: Acarbose
Drug: Glimepiride
Enrollment 380
Recruitment Details  
Pre-assignment Details All participants randomized population. The participant flow module includes the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses and the reason for not completed was a protocol violation.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Period Title: Overall Study
Started 191 190 [1]
Completed 177 164
Not Completed 14 26
Reason Not Completed
Adverse Event             6             4
Lack of Efficacy             0             1
Lost to Follow-up             3             4
Physician Decision             0             3
Protocol Violation             0             2
Withdrawal by Subject             5             12
[1]
Includes the second randomization of a participant
Arm/Group Title Sitagliptin Placebo Total
Hide Arm/Group Description Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.) Total of all reporting groups
Overall Number of Baseline Participants 191 189 380
Hide Baseline Analysis Population Description
All participants randomized population. The baseline characteristics module does not include the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants 189 participants 380 participants
56.5  (8.9) 57.8  (9.5) 57.1  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 189 participants 380 participants
Female
94
  49.2%
92
  48.7%
186
  48.9%
Male
97
  50.8%
97
  51.3%
194
  51.1%
Hemoglobin A1c (A1C)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 191 participants 189 participants 380 participants
8.09  (0.79) 8.08  (0.90) 8.08  (0.85)
[1]
Measure Description: Percent of glycosylated hemoglobin
Fasting plasma glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 191 participants 189 participants 380 participants
177.3  (37.5) 177.5  (40.2) 177.4  (38.8)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Hide Description A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Number of Participants Analyzed 185 180
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.76
(-0.93 to -0.59)
-0.14
(-0.32 to 0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.79 to -0.44
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced at Least One Adverse Event
Hide Description [Not Specified]
Time Frame Up to Week 24 + 14 Day Post-Study Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Number of Participants Analyzed 191 189
Measure Type: Number
Unit of Measure: Participants
62 58
3.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Number of Participants Analyzed 191 189
Measure Type: Number
Unit of Measure: Participants
5 2
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Number of Participants Analyzed 187 183
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-17.9
(-25.3 to -10.5)
-3.5
(-11.1 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-21.8 to -7.0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
 
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
All-Cause Mortality
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/191 (5.24%)      1/189 (0.53%)    
Cardiac disorders     
Cardia flutter  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis chronic  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Cholecystitis  1  2/191 (1.05%)  2 0/189 (0.00%)  0
Infections and infestations     
Gastroenteritis  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive ductal breast carcinoma  1  0/191 (0.00%)  0 1/189 (0.53%)  1
Thymoma  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Transient ischaemic attack  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Renal and urinary disorders     
Calculus urinary  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic  1  1/191 (0.52%)  1 0/189 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/191 (0.00%)      0/189 (0.00%)    
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: NCT01177384     History of Changes
Other Study ID Numbers: 0431-130
2010_543 ( Other Identifier: Merck Registration Number )
CTRI/2011/10/002072 ( Registry Identifier: CTRI )
First Submitted: June 30, 2010
First Posted: August 9, 2010
Results First Submitted: March 10, 2014
Results First Posted: April 28, 2014
Last Update Posted: August 16, 2018