Trial Outcomes & Findings for Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263) (NCT NCT01131182)
NCT ID: NCT01131182
Last Updated: 2022-09-21
Results Overview
Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1147 participants
Primary outcome timeframe
30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Results posted on
2022-09-21
Participant Flow
Of the 1147 participants enrolled in the study, 1066 participants were randomized to treatment.
Participant milestones
| Measure |
Sitagliptin
Sitagliptin 100 mg administered orally daily over the Ramadan period
|
Sulfonylurea
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
|
|---|---|---|
|
Overall Study
STARTED
|
529
|
537
|
|
Overall Study
COMPLETED
|
513
|
521
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
Sitagliptin
Sitagliptin 100 mg administered orally daily over the Ramadan period
|
Sulfonylurea
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
15
|
|
Overall Study
Other Reason
|
1
|
0
|
Baseline Characteristics
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=507 Participants
Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
|
Sulfonylurea
n=514 Participants
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
|
Total
n=1021 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 11 • n=5 Participants
|
55 years
STANDARD_DEVIATION 10 • n=7 Participants
|
55 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
269 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)Population: All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Outcome measures
| Measure |
Sitagliptin
n=507 Participants
Sitagliptin 100 mg administered orally daily over the Ramadan period.
|
Sulfonylurea
n=514 Participants
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
|
|---|---|---|
|
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
|
0.07 proportion of participants
|
0.13 proportion of participants
|
SECONDARY outcome
Timeframe: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)Population: All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.
Outcome measures
| Measure |
Sitagliptin
n=507 Participants
Sitagliptin 100 mg administered orally daily over the Ramadan period.
|
Sulfonylurea
n=514 Participants
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
|
|---|---|---|
|
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
|
0.08 Proportion of participants
|
0.18 Proportion of participants
|
Adverse Events
Sitagliptin
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Sulfonylurea
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=507 participants at risk
Sitagliptin 100 mg administered orally daily over the Ramadan period.
|
Sulfonylurea
n=514 participants at risk
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
0.19%
1/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
0.19%
1/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
0.19%
1/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
Other adverse events
| Measure |
Sitagliptin
n=507 participants at risk
Sitagliptin 100 mg administered orally daily over the Ramadan period.
|
Sulfonylurea
n=514 participants at risk
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
|
|---|---|---|
|
General disorders
Hunger
|
2.6%
13/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
6.8%
35/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Nervous system disorders
Dizziness
|
3.9%
20/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
7.4%
38/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Nervous system disorders
Headache
|
4.9%
25/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
8.6%
44/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Nervous system disorders
Tremor
|
1.4%
7/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
6.6%
34/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.7%
19/507
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
6.2%
32/514
All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER