Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010_538 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period. |
|
| Sulfonylurea | Active Comparator | Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate | Drug | Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21951832 | Result | Al Sifri S, Basiounny A, Echtay A, Al Omari M, Harman-Boehm I, Kaddaha G, Al Tayeb K, Mahfouz AS, Al Elq A, Radican L, Ozesen C, Katzeff HL, Musser BJ, Suryawanshi S, Girman CJ, Davies MJ, Engel SS; 2010 Ramadan Study Group. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. Int J Clin Pract. 2011 Nov;65(11):1132-40. doi: 10.1111/j.1742-1241.2011.02797.x. Epub 2011 Sep 27. | |
| 37435938 |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 1147 participants enrolled in the study, 1066 participants were randomized to treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 100 mg administered orally daily over the Ramadan period |
| FG001 | Sulfonylurea | Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507. |
| BG001 | Sulfonylurea | Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | proportion of participants | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin | Sitagliptin 100 mg administered orally daily over the Ramadan period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hunger | General disorders | MedDRA 13.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharpe & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: Sulfonylurea | Drug | Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription |
|
| Metformin | Drug | Participants could continue pre-study metformin as concomitant therapy during the study. |
|
|
| Derived |
| Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2. |
| Other Reason |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sulfonylurea |
Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. |
|
|
|
| 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. | 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. | Posted | Number | Proportion of participants | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) |
|
|
|
| 0 |
| 507 |
| 34 |
| 507 |
| EG001 | Sulfonylurea | Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. | 3 | 514 | 68 | 514 |
| Urinary Tract Infection | Infections and infestations | MedDRA 13.0 |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 |
|
| Headache | Nervous system disorders | MedDRA 13.0 |
|
| Tremor | Nervous system disorders | MedDRA 13.0 |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |