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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_516 | Other Identifier | Merck Registration ID | |
| MK-0941-018 | Other Identifier | Merck Protocol ID |
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The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receiving placebo tablets three times daily plus insulin injection once daily |
|
| MK-0941 | Experimental | Participants receiving MK-0941 tablets three times daily plus insulin injection once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0941 | Drug | MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) Level | HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels. | Baseline (Day 1) and End of Treatment (Week 20) |
| Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy. | From first dose of study drug (Week 0) to last dose of study drug (Week 20) |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants receiving Placebo tablets 3 times daily plus insulin injection once daily |
| FG001 | MK-0941 | Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants receiving Placebo tablets 3 times daily plus insulin injection once daily |
| BG001 | MK-0941 | Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily |
| 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 | Change From Baseline in Hemoglobin A1c (HbA1c) Level | HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels. | Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement. | Posted | Least Squares Mean | 95% Confidence Interval | % HbA1c | Baseline (Day 1) and End of Treatment (Week 20) |
|
From Screening Visit 2 (Week -10) through to 2 weeks after last dose of randomized study drug (up to 32 weeks)
Reporting of serious AEs includes data after initiation of glycemic rescue therapy. Reporting of non-serious AEs excludes data after initiation of glycemic 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 | Placebo | Participants receiving Placebo tablets 3 times daily plus insulin injection once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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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 |
|---|---|
| C569222 | 3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide |
| D007328 | Insulin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Placebo tablets, taken 3 times daily. |
|
| Insulin | Drug | Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily. |
|
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| Hyperglycemia |
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| Lack of Efficacy |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MK-0941 | Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily |
|
|
|
| Primary | Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy. | All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo). | Posted | Number | participants | From first dose of study drug (Week 0) to last dose of study drug (Week 20) |
|
|
|
|
| 1 |
| 34 |
| 13 |
| 34 |
| EG001 | MK-0941 | Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily | 1 | 34 | 11 | 34 |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
After multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site only. Sponsor can review publications 60 days prior to submission.
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |