Trial Outcomes & Findings for Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (NCT NCT00337610)
NCT ID: NCT00337610
Last Updated: 2016-05-12
Results Overview
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
COMPLETED
PHASE3
190 participants
Baseline and Week 18
2016-05-12
Participant Flow
First Patient In: 21-Aug-2006; Last Patient Last Visit: 15-Aug-2007; Twenty-four medical clinics worldwide (12 in the United States, 2 in Israel, 3 in Mexico, 3 in Peru, and 4 in Austria).
Patients 18-78 years on oral single antihyperglycemic agent (AHA) (hemoglobin A1C \[A1C\] ≥8%) or metformin-based dual combination therapy (A1C 7.5-10.5%) were eligible to participate. Eligible patients underwent an up to 12-week metformin dose-titration/dose-stable period followed by a 2-week placebo run-in period prior to randomization.
Participant milestones
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
94
|
|
Overall Study
Completed Week 18
|
89
|
82
|
|
Overall Study
COMPLETED
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=96 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Placebo
n=94 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 participants
n=5 Participants
|
44 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
31 participants
n=5 Participants
|
24 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
2-Hour Post-Meal Glucose (2 hr PMG)
|
288.7 mg/dL
STANDARD_DEVIATION 74.8 • n=5 Participants
|
286.7 mg/dL
STANDARD_DEVIATION 61.7 • n=7 Participants
|
287.7 mg/dL
STANDARD_DEVIATION 68.5 • n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
201.1 mg/dL
STANDARD_DEVIATION 46.2 • n=5 Participants
|
198.2 mg/dL
STANDARD_DEVIATION 44.6 • n=7 Participants
|
199.7 mg/dL
STANDARD_DEVIATION 45.3 • n=5 Participants
|
|
Hemoglobin A1C (A1C)
|
9.3 Percent
STANDARD_DEVIATION 0.9 • n=5 Participants
|
9.1 Percent
STANDARD_DEVIATION 0.8 • n=7 Participants
|
9.2 Percent
STANDARD_DEVIATION 0.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward (LOCF) method.
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Placebo
n=92 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Sitagliptin 100 mg
n=95 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Change From Baseline in A1C at Week 18
|
0.02 Percent
Interval -0.23 to 0.27
|
-1.00 Percent
Interval -1.24 to -0.75
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Outcome measures
| Measure |
Placebo
n=92 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Sitagliptin 100 mg
n=96 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Change From Baseline in FPG at Week 18
|
-6.5 mg/dL
Interval -15.1 to 2.2
|
-32.0 mg/dL
Interval -40.6 to -23.3
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Outcome measures
| Measure |
Placebo
n=74 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Sitagliptin 100 mg
n=79 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Change From Baseline in 2 Hr-PMG at Week 18
|
-13.5 mg/dL
Interval -28.2 to 1.2
|
-67.6 mg/dL
Interval -82.1 to -53.2
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.
A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Placebo
n=92 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Sitagliptin 100 mg
n=95 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Change From Baseline in A1C at Week 30
|
0.04 Percent
Interval -0.24 to 0.31
|
-0.98 Percent
Interval -1.25 to -0.7
|
Adverse Events
Sitagliptin 100 mg
Placebo
Serious adverse events
| Measure |
Sitagliptin 100 mg
n=96 participants at risk
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Placebo
n=94 participants at risk
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/96 • Weeks 0 to 30
|
1.1%
1/94 • Weeks 0 to 30
|
Other adverse events
| Measure |
Sitagliptin 100 mg
n=96 participants at risk
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
Placebo
n=94 participants at risk
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
5/96 • Weeks 0 to 30
|
5.3%
5/94 • Weeks 0 to 30
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
7/96 • Weeks 0 to 30
|
6.4%
6/94 • Weeks 0 to 30
|
|
Infections and infestations
Pharyngitis
|
4.2%
4/96 • Weeks 0 to 30
|
6.4%
6/94 • Weeks 0 to 30
|
|
Investigations
Blood Glucose Increased
|
6.2%
6/96 • Weeks 0 to 30
|
18.1%
17/94 • Weeks 0 to 30
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
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