Trial Outcomes & Findings for Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262) (NCT NCT01340768)

Results Overview

Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

870 participants

Primary outcome timeframe

Up to 30 days (Day 1 through last day of Ramadan)

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Sitagliptin Sitagliptin 100mg taken orally once daily, with or without metformin	Sulfonylurea Therapy Usual sulfonylurea therapy and dose for each participant, with or without metformin
Overall Study STARTED	436	434
Overall Study COMPLETED	419	429
Overall Study NOT COMPLETED	17	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Sitagliptin 100mg taken orally once daily, with or without metformin	Sulfonylurea Therapy Usual sulfonylurea therapy and dose for each participant, with or without metformin
Overall Study Lost to Follow-up	10	4
Overall Study Withdrawal by Subject	5	1
Overall Study Other	2	0

Baseline Characteristics

Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=421 Participants Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.	Sulfonylurea Therapy n=427 Participants Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.	Total n=848 Participants Total of all reporting groups
Age, Continuous	51.4 years n=5 Participants	50.7 years n=7 Participants	51.0 years n=5 Participants
Sex: Female, Male Female	213 Participants n=5 Participants	233 Participants n=7 Participants	446 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	194 Participants n=7 Participants	402 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days (Day 1 through last day of Ramadan)

Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug.

Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).

Outcome measures

Outcome measures
Measure	Sitagliptin n=421 Participants Sitagliptin 100mg taken orally once daily, with or without metformin	Sulfonylurea Therapy n=427 Participants Usual sulfonylurea therapy and dose for each participant, with or without metformin
Percentage of Participants With at Least One Symptomatic Hypoglycemic Event	3.8 percentage of participants	7.3 percentage of participants

SECONDARY outcome

Timeframe: Up to 30 days (Day 1 through last day of Ramadan)

Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug.

Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.

Outcome measures

Outcome measures
Measure	Sitagliptin n=421 Participants Sitagliptin 100mg taken orally once daily, with or without metformin	Sulfonylurea Therapy n=427 Participants Usual sulfonylurea therapy and dose for each participant, with or without metformin
Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	4.8 percentage of participants	9.6 percentage of participants

Adverse Events

Sitagliptin

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Sulfonylurea Therapy

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sitagliptin n=421 participants at risk Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.	Sulfonylurea Therapy n=427 participants at risk Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.24% 1/421 • Number of events 1	0.00% 0/427

Other adverse events

Other adverse events
Measure	Sitagliptin n=421 participants at risk Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.	Sulfonylurea Therapy n=427 participants at risk Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycemia	3.8% 16/421 • Number of events 19	7.7% 33/427 • Number of events 63

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 The Principal Investigator shall not publish any article or paper nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations, relating or referring to the following: (a) the study or any results, data or insight there from; (b) the services performed; or (c) any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of the sponsor.
Publication restrictions are in place

Restriction type: OTHER