Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.
Detailed description
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Interventions
DRUGSitagliptin phosphate
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
DRUGComparator: Sulfonylurea
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
DRUGMetformin
Participants could continue pre-study metformin as concomitant therapy during the study.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Muslim men and women with type 2 diabetes * Participants who intend to fast during the month of Ramadan * Participants who have been on a stable dose of sulfonylurea for at least three months
Exclusion criteria
* Participants with type 1 diabetes mellitus * Pregnant or breast feeding women * Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment * Participants on insulin * Participants on any class of oral diabetic therapy other than sulfonylurea or metformin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With at Least One Symptomatic Hypoglycemic Event | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) | 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. |
Participant flow
Pre-assignment details
Of the 1147 participants enrolled in the study, 1066 participants were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507. | 507 |
| Sulfonylurea Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514. | 514 |
| Total | 1,021 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 15 |
| Overall Study | Other Reason | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Sitagliptin | Sulfonylurea | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 10 | 55 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 238 Participants | 259 Participants | 497 Participants |
| Sex: Female, Male Male | 269 Participants | 255 Participants | 524 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 507 | 68 / 514 |
| serious Total, serious adverse events | 0 / 507 | 3 / 514 |
Outcome results
Primary
Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Proportion of Participants With at Least One Symptomatic Hypoglycemic Event | 0.07 proportion of participants |
| Sulfonylurea | Proportion of Participants With at Least One Symptomatic Hypoglycemic Event | 0.13 proportion of participants |
p-value: 0.0005Cochran-Mantel-Haenszel
Secondary
Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 0.08 Proportion of participants |
| Sulfonylurea | Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 0.18 Proportion of participants |