Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00875394
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : April 20, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Non-Insulin-Dependent
Interventions Drug: sitagliptin phosphate
Drug: Comparator: metformin
Drug: Comparator: Antidiabetic Standard of Care
Enrollment 68
Recruitment Details

Patients were recruited in Principal Investigator's private practice, in Mexico City.

First Patient Entered: 15 Feb 2007. Last Patient's Last Visit: 27 Jun 2008
Pre-assignment Details Patients 30 to 78 years of age with inadequate glycemic control (Glycosylated hemoglobin A1C (A1C) 6.5 to 11%) on diet/exercise and metformin dosed at ≥1500 mg per day patients were to receive either sitagliptin added to ongoing metformin or "standard care" added to ongoing metformin.
Arm/Group Title Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Hide Arm/Group Description Patients administered sitagliptin and metformin Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
Period Title: Overall Study
Started 36 23 9
Completed 36 23 9
Not Completed 0 0 0
Arm/Group Title Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone Total
Hide Arm/Group Description Patients administered sitagliptin and metformin Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". Total of all reporting groups
Overall Number of Baseline Participants 36 23 9 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 23 participants 9 participants 68 participants
54.2  (9.8) 56.0  (8.5) 53.3  (11.7) 54.69  (9.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 23 participants 9 participants 68 participants
Female
25
  69.4%
19
  82.6%
6
  66.7%
50
  73.5%
Male
11
  30.6%
4
  17.4%
3
  33.3%
18
  26.5%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 36 participants 23 participants 9 participants 68 participants
29.0  (4.5) 28.8  (5.1) 28.3  (5.2) 28.84  (4.74)
Glycosylated Hemoglobin A1C (A1C)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 36 participants 23 participants 9 participants 68 participants
8.8  (1.5) 8.0  (1.8) 8.2  (1.1) 8.47  (1.61)
Time since diagnosis of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 23 participants 9 participants 68 participants
8.9  (7.1) 6.8  (8.5) 10.9  (7.7) 8.43  (7.68)
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24
Hide Description Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
Arm/Group Title Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Hide Arm/Group Description:
Patients administered sitagliptin and metformin.
Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Hide Arm/Group Description Patients administered sitagliptin and metformin Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care". Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving "standard care".
All-Cause Mortality
Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/23 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin + Metformin Metformin + Any Non-DPP-4i Oral Antidiabetic Drug Metformin Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   1/23 (4.35%)   0/9 (0.00%) 
Gastrointestinal disorders       
Nausea 1  0/36 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough 1  0/36 (0.00%)  1/23 (4.35%)  0/9 (0.00%) 
1
Term from vocabulary, MEDRA 13.1

A limited number of participants were recruited into this open-label study. This study was conducted at a single site.

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

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
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00875394     History of Changes
Other Study ID Numbers: 0431-189
2009_571
First Submitted: April 1, 2009
First Posted: April 3, 2009
Results First Submitted: June 12, 2009
Results First Posted: April 20, 2011
Last Update Posted: May 30, 2017