Trial Outcomes & Findings for Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045) (NCT NCT00758069)
NCT ID: NCT00758069
Last Updated: 2017-05-05
Results Overview
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2017-05-05
Participant Flow
Phase II. First patient in: 31 July 2005. Last patient, last visit: 13 February 2006. The study was conducted at 8 centers in Japan.
Patients 20-69 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and \<10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
Participant milestones
| Measure |
Sitagliptin 100 mg QD
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
28
|
|
Overall Study
COMPLETED
|
26
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg QD
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Incorrect Study Drug
|
1
|
0
|
0
|
Baseline Characteristics
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg QD
n=27 Participants
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
n=25 Participants
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
n=28 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Fasting Plasma Glucose (FPG)
|
158.6 mg/dL
STANDARD_DEVIATION 41.0 • n=5 Participants
|
156.4 mg/dL
STANDARD_DEVIATION 41.3 • n=7 Participants
|
164.1 mg/dL
STANDARD_DEVIATION 36.9 • n=5 Participants
|
159.9 mg/dL
STANDARD_DEVIATION 39.3 • n=4 Participants
|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
24-hour weighted mean plasma glucose (24hr-WMG)
|
195.0 mg/dL
STANDARD_DEVIATION 55.6 • n=5 Participants
|
188.9 mg/dL
STANDARD_DEVIATION 46.6 • n=7 Participants
|
195.4 mg/dL
STANDARD_DEVIATION 46.2 • n=5 Participants
|
193.2 mg/dL
STANDARD_DEVIATION 49.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg QD
n=25 Participants
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
n=24 Participants
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
n=27 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Plasma Glucose
|
-34.9 mg/dL
Interval -40.9 to 28.9
|
-28.6 mg/dL
Interval -34.7 to 22.4
|
-9.0 mg/dL
Interval -14.8 to -3.2
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.
Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg QD
n=25 Participants
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
n=24 Participants
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
n=27 Participants
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Change From Baseline in Plasma Glucose
|
-22.3 mg/dL
Interval -27.7 to 17.0
|
-16.0 mg/dL
Interval -21.4 to 10.6
|
-3.1 mg/dL
Interval -8.2 to 2.0
|
Adverse Events
Sitagliptin 100 mg QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Sitagliptin 50 mg BID
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg QD
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
3.7%
1/27
|
8.0%
2/25
|
0.00%
0/28
|
Other adverse events
| Measure |
Sitagliptin 100 mg QD
The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
|
Sitagliptin 50 mg BID
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
|
Placebo
The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27
|
4.0%
1/25
|
7.1%
2/28
|
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