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The primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C) after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will be randomized to either sitagliptin or glimepiride treatment after eligibility for study participation is determined during screening and washout study phases. Participants and study staff will not know to which treatment group they have been randomized (double-blind design). The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3) oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of treatment with study medication.
The dose of sitagliptin will be 100 mg once daily (QD) or 50 mg QD based on the participant's estimated glomerular filtration rate (eGFR). The starting dose of glimepiride (1 mg QD) may be up-titrated as needed to optimize glycemic control over the first 18 weeks to a maximum dose of 6 mg/day, after which the dose will not be increased for the rest of the study (down-titration to avoid or control hypoglycemia is allowed).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin phosphate 100 mg or 50 mg once daily (QD) |
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| Glimepiride | Active Comparator | Glimepiride 1-6 mg QD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Sitagliptin tablets, orally, at a dose of 100 mg or 50 mg QD for 30 weeks. The dose level to be administered will depend on the participant's estimated glomerular filtration rate (eGFR), calculated at Visit 3 and may be adjusted as medically indicated during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. | Baseline and Week 30 |
| Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms. | Up to Week 30 |
| Number of Participants Experiencing An Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. | Up to Week 30 |
| Number of Participants Discontinuing Study Treatment Due to An AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. | Up to Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG. | Baseline and Week 30 |
| Percentage of Participants With HbA1c <7.0% at Week 30 |
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Inclusion Criteria
Exclusion Criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26041585 | Result | Hartley P, Shentu Y, Betz-Schiff P, Golm GT, Sisk CM, Engel SS, Shankar RR. Efficacy and Tolerability of Sitagliptin Compared with Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control: A Randomized, Double-Blind, Non-Inferiority Trial. Drugs Aging. 2015 Jun;32(6):469-76. doi: 10.1007/s40266-015-0271-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD |
| FG001 | Glimepiride | Glimepiride 1-6 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Glimepiride | Drug | Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks. The dose may also be decreased as medically indicated during the study. |
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| Placebo to Sitagliptin | Drug | Matching placebo tablets to sitagliptin to allow for blinding. |
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| Placebo to Glimepiride | Drug | Matching placebo tablets to glimepiride to allow for blinding. |
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Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. |
| Week 30 |
| Percentage of Participants With HbA1c <6.5% at Week 30 | Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. | Week 30 |
| LS Mean Change From Baseline in Participant Body Weight at Week 30 | Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30. | Baseline and Week 30 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD |
| BG001 | Glimepiride | Glimepiride 1-6 mg QD |
| 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 (HbA1c) | The population included all randomized participants who had a baseline HbA1c, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. Sitagliptin (n=197) and glimepiride (n=191). | Mean | Standard Deviation | Percentage of HbA1c |
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| Fasting Plasma Glucose (FPG) | The population included all randomized participants who had a baseline FPG, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. Sitagliptin (n=194) and glimepiride (n=191). | Mean | Standard Deviation | mg/dL |
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| Body Weight | All randomized participants who received at least one dose of study treatment and had a body weight measurement at baseline. Sitagliptin (n=205) and glimepiride (n=203). | Mean | Standard Deviation | kg |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30 | Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. | The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of HbA1c | Baseline and Week 30 |
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| Primary | Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 | Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to Week 30 |
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| Primary | Number of Participants Experiencing An Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to Week 30 |
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| Primary | Number of Participants Discontinuing Study Treatment Due to An AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Participants | Up to Week 30 |
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| Secondary | LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 | Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG. | The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 30 |
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| Secondary | Percentage of Participants With HbA1c <7.0% at Week 30 | Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. | The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. | Posted | Number | Percentage of Participants | Week 30 |
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| Secondary | Percentage of Participants With HbA1c <6.5% at Week 30 | Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. | The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. | Posted | Number | Percentage of Participants | Week 30 |
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| Secondary | LS Mean Change From Baseline in Participant Body Weight at Week 30 | Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30. | All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and Week 30 |
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Up to Week 32.
The safety population consisted of all randomized participants who received at least one dose of study treatment.
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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 phosphate 100 mg once daily (QD) or 50 mg QD | 7 | 241 | 34 | 241 | ||
| EG001 | Glimepiride | Glimepiride 1-6 mg QD | 6 | 236 | 40 | 236 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
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| Angina Unstable | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Cardiac Failure Chronic | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
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| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
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| Nerve Compression | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
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Investigator may publish results for his/her study site after publication of results of entire multicenter trial, or after public disclosure of the results online if a multicenter manuscript is not planned. Sponsor must be able to review all proposed results communications regarding study 60 days prior to submission for publication/presentation. 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 |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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