Trial Outcomes & Findings for Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED) (NCT NCT00305604)
NCT ID: NCT00305604
Last Updated: 2017-05-11
Results Overview
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-05-11
Participant Flow
First Patient In: 30-MAR-2006 Last Patient Last Visit: 12-MAR-2008 60 medical clinics in the United States.
Community dwelling patients ≥ 65 years of age with a diagnosis of type 2 diabetes with hemoglobin A1c (HbA1c) ≥ 7% and ≤ 10% on diet and exercise were eligible to participate. Following a variable duration screening period, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d. based on creatinine clearance) and placebo.
Participant milestones
| Measure |
Sitagliptin
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
104
|
|
Overall Study
COMPLETED
|
70
|
57
|
|
Overall Study
NOT COMPLETED
|
32
|
47
|
Reasons for withdrawal
| Measure |
Sitagliptin
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
11
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
21
|
|
Overall Study
Patient moved
|
1
|
0
|
Baseline Characteristics
Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=102 Participants
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
n=104 Participants
Sitagliptin-matching placebo tablets.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
72.1 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
71.9 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
76 participants
n=5 Participants
|
86 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
HbA1c (Hemoglobin A1c)
|
7.8 Percent
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.8 Percent
STANDARD_DEVIATION 0.7 • n=7 Participants
|
7.8 Percent
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all patients with a baseline value and \>= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin
n=101 Participants
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
n=91 Participants
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24
|
-0.47 Percent
Interval -0.69 to -0.25
|
0.23 Percent
Interval 0.0 to 0.47
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all patients with a baseline value and \>= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin
n=96 Participants
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
n=88 Participants
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
|
-16.2 mg/dL
Interval -28.9 to -3.6
|
10.6 mg/dL
Interval -2.7 to 23.9
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all patients with a baseline value and \>= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin
n=74 Participants
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
n=68 Participants
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
|
-52.1 mg/dL
Interval -73.6 to -30.7
|
8.9 mg/dL
Interval -12.4 to 30.1
|
SECONDARY outcome
Timeframe: Week 1Population: The Full Analysis Set (FAS) included all patients with a baseline value and \>= 1 post-baseline value for this outcome. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.
Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.
Outcome measures
| Measure |
Sitagliptin
n=59 Participants
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
n=62 Participants
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week
|
-25.7 mg/dL
Interval -34.2 to -17.1
|
-2.1 mg/dL
Interval -10.7 to 6.4
|
Adverse Events
Sitagliptin
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Cardiac disorders
Any Cardiac disorders
|
0.98%
1/102
|
3.8%
4/104
|
|
Cardiac disorders
Coronary Artery Disease
|
0.98%
1/102
|
2.9%
3/104
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/102
|
0.96%
1/104
|
|
Gastrointestinal disorders
Any Gastrointestinal disorders
|
0.00%
0/102
|
1.9%
2/104
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/102
|
0.96%
1/104
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.00%
0/102
|
0.96%
1/104
|
|
Hepatobiliary disorders
Any Hepatobiliary disorders
|
0.00%
0/102
|
0.96%
1/104
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/102
|
0.96%
1/104
|
|
Infections and infestations
Any Infections and infestations
|
2.9%
3/102
|
2.9%
3/104
|
|
Infections and infestations
Bronchitis
|
0.98%
1/102
|
0.00%
0/104
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/102
|
0.96%
1/104
|
|
Infections and infestations
Mycobacterium Avium Complex Infection
|
0.00%
0/102
|
0.96%
1/104
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102
|
0.96%
1/104
|
|
Infections and infestations
Sinusitis
|
0.98%
1/102
|
0.00%
0/104
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.98%
1/102
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Any Injury, poisoning and procedural complications
|
0.00%
0/102
|
1.9%
2/104
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/102
|
0.96%
1/104
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/102
|
0.96%
1/104
|
|
Metabolism and nutrition disorders
Any Metabolism and nutrition disorders
|
0.00%
0/102
|
0.96%
1/104
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102
|
0.96%
1/104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Neoplasms benign, malignant and unspecified
|
2.9%
3/102
|
0.00%
0/104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
2.0%
2/102
|
0.00%
0/104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.98%
1/102
|
0.00%
0/104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.98%
1/102
|
0.00%
0/104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.98%
1/102
|
0.00%
0/104
|
|
Renal and urinary disorders
Any Renal and urinary disorders
|
0.00%
0/102
|
1.9%
2/104
|
|
Renal and urinary disorders
Bladder Obstruction
|
0.00%
0/102
|
0.96%
1/104
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/102
|
0.96%
1/104
|
|
Reproductive system and breast disorders
Any Reproductive system and breast disorders
|
0.00%
0/102
|
0.96%
1/104
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/102
|
0.96%
1/104
|
|
Respiratory, thoracic and mediastinal disorders
Any Respiratory, thoracic and mediastinal disorders
|
0.00%
0/102
|
0.96%
1/104
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/102
|
0.96%
1/104
|
Other adverse events
| Measure |
Sitagliptin
Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \< 50 mL/min at any time during the study.
|
Placebo
Sitagliptin-matching placebo tablets.
|
|---|---|---|
|
Infections and infestations
Any Infections and Infestations
|
3.9%
4/102
|
5.8%
6/104
|
|
Infections and infestations
Urinary Tract Infection
|
3.9%
4/102
|
5.8%
6/104
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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