Type 2 Diabetes Mellitus
Conditions
Keywords
Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
Brief summary
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.
Detailed description
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Interventions
DRUGSitagliptin
One 100 mg tablet taken orally once daily
DRUGSulfonylurea
Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
DRUGMetformin
Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.
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, with type 2 diabetes mellitus * Intends to fast during the month of Ramadan * Hemoglobin A1c (HbA1c) ≤10% at screening * On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose
Exclusion criteria
* Type 1 diabetes mellitus * Pregnant or breast feeding or with gestational diabetes * Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment * Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females) * History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization) * Any use of insulin (prior to or during Ramadan) * Use of any class of oral antidiabetic therapy other than an SU or metformin * Current participation in another interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Up to 30 days (Day 1 through last day of Ramadan) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 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. | 421 |
| Sulfonylurea Therapy 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. | 427 |
| Total | 848 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 4 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Sitagliptin | Sulfonylurea Therapy | Total |
|---|---|---|---|
| Age, Continuous | 51.4 years | 50.7 years | 51.0 years |
| Sex: Female, Male Female | 213 Participants | 233 Participants | 446 Participants |
| Sex: Female, Male Male | 208 Participants | 194 Participants | 402 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 421 | 33 / 427 |
| serious Total, serious adverse events | 1 / 421 | 0 / 427 |
Outcome results
Primary
Percentage of Participants With at Least One Symptomatic Hypoglycemic Event
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | 3.8 percentage of participants |
| Sulfonylurea Therapy | Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | 7.3 percentage of participants |
p-value: 0.02895% CI: [0.29, 0.94]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 4.8 percentage of participants |
| Sulfonylurea Therapy | Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 9.6 percentage of participants |
p-value: 0.00695% CI: [0.29, 0.83]Cochran-Mantel-Haenszel