Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158) (NCT NCT00832390)
NCT ID: NCT00832390
Last Updated: 2017-05-30
Results Overview
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Baseline and 24 Weeks
Results posted on
2017-05-30
Participant Flow
Single site study with patients recruited in Principal Investigator's private practice, Mexico City. First Patient In: 14Feb2007. Last Patient's Last Visit: 11Jul2008
Treatment naïve patients (30 to 78 years of age) with inadequate glycemic control on diet/exercise were assigned to treatment with sitagliptin alone (A1C 6.5 to \<8%), sitagliptin + metformin as initial combination therapy (A1C 8-12%), or standard care.
Participant milestones
| Measure |
Sitagliptin 100 mg q.d. (Once Daily)
|
Sitagliptin 100 mg q.d. (Once Daily) and Metformin
|
Standard Care Regimen
Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
1
|
|
Overall Study
COMPLETED
|
12
|
16
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg q.d. (Once Daily)
n=12 Participants
|
Sitagliptin 100 mg q.d. (Once Daily) and Metformin
n=16 Participants
|
Standard Care Regimen
n=1 Participants
Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
54.62 years
STANDARD_DEVIATION 11.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
27.4 kg/m2
STANDARD_DEVIATION 10.0 • n=5 Participants
|
28.9 kg/m2
STANDARD_DEVIATION 5.2 • n=7 Participants
|
26.0 kg/m2
STANDARD_DEVIATION 0.0 • n=5 Participants
|
28.14 kg/m2
STANDARD_DEVIATION 7.41 • n=4 Participants
|
|
Glycosylated Hemoglobin A1C (A1C)
|
7.1 Percent
STANDARD_DEVIATION 0.6 • n=5 Participants
|
8.6 Percent
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.9 Percent
STANDARD_DEVIATION 0.0 • n=5 Participants
|
7.96 Percent
STANDARD_DEVIATION 1.33 • n=4 Participants
|
|
Time Since Diagnosis of Diabetes
|
5.3 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
6.2 Years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
5.2 Years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
5.82 Years
STANDARD_DEVIATION 6.25 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksWeek 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. (Once Daily)
n=12 Participants
|
Sitagliptin 100 mg q.d. (Once Daily) and Metformin
n=16 Participants
|
Standard Care Regimen
n=1 Participants
Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group.
|
|---|---|---|---|
|
Change From Baseline in A1C at Week 24
|
-0.2 Percent Difference
Interval -0.9 to 0.5
|
-1.0 Percent Difference
Interval -2.1 to -0.1
|
0.0 Percent Difference
Interval 0.0 to 0.0
|
Adverse Events
Sitagliptin 100 mg q.d. (Once Daily)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sitagliptin 100 mg q.d. (Once Daily) and Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin 100 mg q.d. (Once Daily)
n=12 participants at risk
|
Sitagliptin 100 mg q.d. (Once Daily) and Metformin
n=16 participants at risk
|
Standard Care Regimen
n=1 participants at risk
Patients in the "standard care" group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
8.3%
1/12
|
0.00%
0/16
|
0.00%
0/1
|
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