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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2011/06/001838 | Registry Identifier | CTRI |
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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.
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100mg taken orally once daily with or without metformin |
|
| Sulfonylurea Therapy | Active Comparator | Usual sulfonylurea therapy with or without metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | One 100 mg tablet taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 30 days (Day 1 through last day of Ramadan) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37435938 | 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. | |
| 22738801 | Derived | Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, Suryawanshi S, Davies MJ, Girman CJ, Katzeff HL, Radican L, Engel SS, Wolthers T. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 100mg taken orally once daily, with or without metformin |
| FG001 | Sulfonylurea Therapy | Usual sulfonylurea therapy and dose for each participant, with or without metformin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sulfonylurea Therapy |
| 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 | 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). | All participants as treated population defined as all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Up to 30 days (Day 1 through last day of Ramadan) |
|
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| 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 13.0 | Hypoglycemia includes both symptomatic hypoglycemia and asymptomatic hypoglycemia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & 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 |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D013453 | Sulfonylurea Compounds |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sulfonylurea | Drug | Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide. |
|
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| Metformin | Drug | 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. |
|
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| Up to 30 days (Day 1 through last day of Ramadan) |
| Other |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Usual sulfonylurea therapy and dose for each participant, with or without metformin |
|
|
|
| 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. | All participants as treated population defined as all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Up to 30 days (Day 1 through last day of Ramadan) |
|
|
|
|
| 1 |
| 421 |
| 16 |
| 421 |
| EG001 | 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. | 0 | 427 | 33 | 427 |
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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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |