Trial Outcomes & Findings for ALPHA Sitagliptin Add on to Metformin (0431-103) (NCT NCT00833027)
NCT ID: NCT00833027
Last Updated: 2017-05-15
Results Overview
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
608 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-05-15
Participant Flow
First patient in: 11-MAR-2008 Last patient out: 30-OCT-2009 Total number of sites: 110
Participant milestones
| Measure |
Sitagliptin 100mg
|
|---|---|
|
Overall Study
STARTED
|
608
|
|
Overall Study
COMPLETED
|
397
|
|
Overall Study
NOT COMPLETED
|
211
|
Reasons for withdrawal
| Measure |
Sitagliptin 100mg
|
|---|---|
|
Overall Study
Adverse Event
|
33
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
Protocol Violation
|
115
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Missing
|
10
|
Baseline Characteristics
ALPHA Sitagliptin Add on to Metformin (0431-103)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100mg
n=608 Participants
|
|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
491 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Indian
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.73 percent
STANDARD_DEVIATION 1.11 • n=5 Participants
|
|
Weight
|
92.6 Kilograms
STANDARD_DEVIATION 24.42 • n=5 Participants
|
|
Fasting plasma glucose
|
9.3 mmol/L
STANDARD_DEVIATION 2.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Includes all patients who received at least one dose of study medication and have a Week 24 measure.
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent
Outcome measures
| Measure |
Sitagliptin 100mg
n=375 Participants
|
|---|---|
|
Change From Baseline in HbA1c at Week 24
|
-0.6 Percent
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Includes all patients who received at least one dose of study medication and have a Week 12 measure.
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent
Outcome measures
| Measure |
Sitagliptin 100mg
n=406 Participants
|
|---|---|
|
Change From Baseline in HbA1c at Week 12
|
-0.6 Percent
Standard Deviation 0.85
|
Adverse Events
Sitagliptin 100mg
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100mg
n=608 participants at risk
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.33%
2/608 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
1/608 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.16%
1/608 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/608 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/608 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.16%
1/608 • Number of events 1
|
|
General disorders
Chest pain
|
0.49%
3/608 • Number of events 3
|
|
General disorders
Sudden death
|
0.16%
1/608 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.16%
1/608 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.16%
1/608 • Number of events 1
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.16%
1/608 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.16%
1/608 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.16%
1/608 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.16%
1/608 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.16%
1/608 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/608 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.16%
1/608 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.49%
3/608 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
1/608 • Number of events 1
|
Other adverse events
Adverse event data not reported
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