A Phase 4 interventional study of Sitagliptin phosphate and Comparator: Sulfonylurea in Type 2 Diabetes Mellitus (T2DM), sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment
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.
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,147 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Drug: Sitagliptin phosphate · Drug: Metformin
Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Drug: Comparator: Sulfonylurea · Drug: Metformin
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
Also known as: Januvia
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
Participants could continue pre-study metformin as concomitant therapy during the study.
Also known as: Glucophage
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)
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)
| Milestone | Sitagliptin | Sulfonylurea |
|---|---|---|
| Started | 529 | 537 |
| Completed | 513 | 521 |
| Not completed | 16 | 16 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Lost to follow-up | 14 | 15 |
| Withdrew: Other reason | 1 | 0 |
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.
| proportion of participants | Sitagliptin | Sulfonylurea |
|---|---|---|
| Proportion of Participants With at Least One Symptomatic Hypoglycemic Event | 0.07 | 0.13 |
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.
| Proportion of participants | Sitagliptin | Sulfonylurea |
|---|---|---|
| Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 0.08 | 0.18 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin | — | 0/507 (0%) | 34/507 (6.7%) |
| Sulfonylurea | — | 3/514 (0.6%) | 68/514 (13.2%) |
| Event | Sitagliptin | Sulfonylurea |
|---|---|---|
| Pancreatitis acuteGastrointestinal disorders | 0/507 | 1/514 |
| Urinary Tract InfectionInfections and infestations | 0/507 | 1/514 |
| Ischaemic strokeNervous system disorders | 0/507 | 1/514 |
| Event | Sitagliptin | Sulfonylurea |
|---|---|---|
| HeadacheNervous system disorders | 25/507 | 44/514 |
| DizzinessNervous system disorders | 20/507 | 38/514 |
| HungerGeneral disorders | 13/507 | 35/514 |
| TremorNervous system disorders | 7/507 | 34/514 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 19/507 | 32/514 |
| Age, Continuous(years) | Sitagliptin | Sulfonylurea | Total |
|---|---|---|---|
| Mean | 55 ± 11 | 55 ± 10 | 55 ± 11 |
| Sex: Female, Male(Participants) | Sitagliptin | Sulfonylurea | Total |
|---|---|---|---|
| Female | 238 | 259 | 497 |
| Male | 269 | 255 | 524 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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