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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_543 | Other Identifier | Merck Registration Number | |
| CTRI/2011/10/002072 | Registry Identifier | CTRI |
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This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C) more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg once daily (q.d.) reduces A1C more than the addition of placebo in participants with T2DM with inadequate glycemic control on acarbose monotherapy.
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.
*: Wash-off only applicable to patients who were on acarbose and another AHA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) |
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| Placebo | Placebo Comparator | Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate | Drug | Sitagliptin, 100 mg tablet once daily, orally for 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy. | Baseline and Week 24 |
| Number of Participants Who Experienced at Least One Adverse Event | Up to Week 24 + 14 Day Post-Study Follow-up | |
| Number of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy. | Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28035868 | Derived | Wang W, Ning G, Ma J, Liu X, Zheng S, Wu F, Xu L, O'Neill EA, Fujita KP, Engel SS, Kaufman KD, Shankar RR. A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone. Curr Med Res Opin. 2017 Apr;33(4):693-699. doi: 10.1080/03007995.2016.1277200. Epub 2017 Jan 25. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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All participants randomized population. The participant flow module includes the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses and the reason for not completed was a protocol violation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) |
| FG001 | Placebo | Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Placebo | Drug | Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks |
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| Acarbose | Drug | Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks |
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| Glimepiride | Drug | Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy. |
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| COMPLETED |
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| NOT COMPLETED |
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All participants randomized population. The baseline characteristics module does not include the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) |
| BG001 | Placebo | Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Hemoglobin A1c (A1C) | Percent of glycosylated hemoglobin | Mean | Standard Deviation | Percent |
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| Fasting plasma glucose | Mean | Standard Deviation | mg/dL |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy. | Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach). | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy. | Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
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| Primary | Number of Participants Who Experienced at Least One Adverse Event | All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy. | Posted | Number | Participants | Up to Week 24 + 14 Day Post-Study Follow-up |
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| Primary | Number of Participants Who Discontinued Study Drug Due to an Adverse Event | All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy. | Posted | Number | Participants | Up to 24 Weeks |
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All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
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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 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.]) | 10 | 191 | 0 | 191 | ||
| EG001 | Placebo | Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.) | 1 | 189 | 0 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardia flutter | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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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.
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D020909 | Acarbose |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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