Trial Outcomes & Findings for Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049) (NCT NCT00449930)
NCT ID: NCT00449930
Last Updated: 2017-05-11
Results Overview
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1050 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2017-05-11
Participant Flow
First patient In: 04-Apr-2007 Last Patient Last Visit: 25-Jul-2008 113 study centers worldwide
Patients 18-78 years of age with Type 2 diabetes mellitus (T2DM) who were not on anti-hyperglycemic agents for at least 4 months (16 weeks) and with a hemoglobin A1c (HbA1c) of ≥ 6.5 and ≤9.0%
Participant milestones
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
Metformin
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
|---|---|---|
|
Overall Study
STARTED
|
528
|
522
|
|
Overall Study
COMPLETED
|
467
|
447
|
|
Overall Study
NOT COMPLETED
|
61
|
75
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
Metformin
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
19
|
|
Overall Study
Trial Terminated ( Site Closed)
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
10
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
14
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Protocol Violation
|
14
|
15
|
|
Overall Study
Withdrawal by Subject
|
16
|
23
|
|
Overall Study
Glycemic discontinuation criteria
|
1
|
1
|
Baseline Characteristics
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=528 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
Metformin
n=522 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Total
n=1050 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
566 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
484 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
397 participants
n=5 Participants
|
395 participants
n=7 Participants
|
792 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
64 participants
n=5 Participants
|
62 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Body Weight
|
84.9 Kilograms
STANDARD_DEVIATION 17.7 • n=5 Participants
|
84.6 Kilograms
STANDARD_DEVIATION 17.2 • n=7 Participants
|
84.7 Kilograms
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.2 Percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.3 Percent
STANDARD_DEVIATION 0.7 • n=7 Participants
|
7.3 Percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance \<85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Metformin
n=439 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Sitagliptin 100 mg
n=455 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
|
-0.57 Percent
Interval -0.62 to -0.51
|
-0.43 Percent
Interval -0.48 to -0.38
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All randomized patients who received at least 1 dose of the double-blind study therapy.
Outcome measures
| Measure |
Metformin
n=522 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Sitagliptin 100 mg
n=528 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
|---|---|---|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Patients Who Reported Diarrhea
|
57 Participants
|
19 Participants
|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
Patients Who Did Not Report Diarrhea
|
465 Participants
|
509 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All randomized patients who received at least 1 dose of the double-blind study therapy.
Outcome measures
| Measure |
Metformin
n=522 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Sitagliptin 100 mg
n=528 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
|---|---|---|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Patients Who Reported Nausea
|
16 Participants
|
6 Participants
|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
Patients Who Did Not Report Nausea
|
506 Participants
|
522 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All randomized patients who received at least 1 dose of the double-blind study therapy.
Outcome measures
| Measure |
Metformin
n=522 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Sitagliptin 100 mg
n=528 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
|---|---|---|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Patients Who Reported Abdominal Pain
|
20 Participants
|
11 Participants
|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
Patients Who Did Not Report Abdominal Pain
|
502 Participants
|
517 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: All randomized patients who received at least 1 dose of the double-blind study therapy.
Outcome measures
| Measure |
Metformin
n=522 Participants
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
Sitagliptin 100 mg
n=528 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
|---|---|---|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Patients Who Reported Vomiting
|
7 Participants
|
2 Participants
|
|
Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
Patients Who Did Not Report Vomiting
|
515 Participants
|
526 Participants
|
Adverse Events
Sitagliptin 100 mg
Serious events: 10 serious events
Other events: 19 other events
Deaths: 0 deaths
Metformin
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
Metformin
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
|---|---|---|
|
Cardiac disorders
Any Cardiac disorders
|
0.19%
1/528
|
0.57%
3/522
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/528
|
0.19%
1/522
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/528
|
0.00%
0/522
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/528
|
0.19%
1/522
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/528
|
0.19%
1/522
|
|
Congenital, familial and genetic disorders
Any Congenital, familial and genetic disorders
|
0.00%
0/528
|
0.19%
1/522
|
|
Congenital, familial and genetic disorders
Multiple endocrine adenomatosis Type II
|
0.00%
0/528
|
0.19%
1/522
|
|
General disorders
Any General disorders and administration site conditions
|
0.00%
0/528
|
0.19%
1/522
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/528
|
0.19%
1/522
|
|
Infections and infestations
Any Infections and infestations
|
0.38%
2/528
|
0.38%
2/522
|
|
Infections and infestations
Appendicitis
|
0.19%
1/528
|
0.00%
0/522
|
|
Infections and infestations
Cellulitis
|
0.00%
0/528
|
0.19%
1/522
|
|
Infections and infestations
Gastroenteritis
|
0.19%
1/528
|
0.00%
0/522
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/528
|
0.19%
1/522
|
|
Injury, poisoning and procedural complications
Any Injury, poisoning and procedural complications
|
0.57%
3/528
|
0.00%
0/522
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.19%
1/528
|
0.00%
0/522
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.19%
1/528
|
0.00%
0/522
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.19%
1/528
|
0.00%
0/522
|
|
Metabolism and nutrition disorders
Any Metabolism and nutrition disorders
|
0.19%
1/528
|
0.00%
0/522
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.19%
1/528
|
0.00%
0/522
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Neoplasms benign, malignant and unspecified
|
0.19%
1/528
|
0.19%
1/522
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.19%
1/528
|
0.00%
0/522
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/528
|
0.19%
1/522
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.19%
1/528
|
0.00%
0/522
|
|
Nervous system disorders
Any Nervous system disorders
|
0.19%
1/528
|
0.00%
0/522
|
|
Nervous system disorders
Facial palsy
|
0.19%
1/528
|
0.00%
0/522
|
|
Renal and urinary disorders
Any Renal and urinary disorders
|
0.19%
1/528
|
0.00%
0/522
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/528
|
0.00%
0/522
|
|
Reproductive system and breast disorders
Any Reproductive system and breast disorders
|
0.00%
0/528
|
0.19%
1/522
|
|
Reproductive system and breast disorders
Hydrometra
|
0.00%
0/528
|
0.19%
1/522
|
Other adverse events
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
|
Metformin
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
|
|---|---|---|
|
Gastrointestinal disorders
Any Gastrointestinal disorders
|
3.6%
19/528
|
10.9%
57/522
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
19/528
|
10.9%
57/522
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER