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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_596 | |||
| MK-0941-006 |
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A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-0941 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0941 | Drug | In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments. Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event During the Study | 39 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event - Titration Scheme 1 | In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study. | 25 days |
| Number of Participants Who Experienced an Adverse Event - Titration Scheme 2 |
Not provided
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 | MK-0941 | Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin. |
| FG001 | Placebo | Participants receiving placebo while on basal insulin. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0941 | Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin. |
| BG001 | Placebo | Participants receiving placebo while on basal insulin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants Who Experienced an Adverse Event During the Study | All participants who experienced one or more adverse events during the study | Posted | Number | participants | 39 days |
|
|
25 days
All participants who received at least 1 dose of study drug
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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 | MK-0941 Titration 1 | Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Injuries | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye 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 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Placebo | Drug | 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c. |
|
| LANTUS insulin | Drug | LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin |
|
|
Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration. |
| 25 days |
| 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 | Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7. | 24 hours |
| Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period | During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home. | Outpatient Days 1 to 14 |
| Not reported |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event - Titration Scheme 1 | In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study. | All participants who experienced one or more adverse events within 25 days of Titration Scheme 1 | Posted | Number | participants | 25 days |
|
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event - Titration Scheme 2 | Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration. | All participants who experienced one or more adverse events within 25 days of Titration Scheme 2 | Posted | Number | participants | 25 days |
|
|
|
| Secondary | 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 | Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7. | All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7 | Posted | Least Squares Mean | Standard Deviation | mg/dL | 24 hours |
|
|
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period | During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home. | All participants who experienced one or more adverse events during the Outpatient Treatment Period. | Posted | Number | participants | Outpatient Days 1 to 14 |
|
|
|
| 0 |
| 23 |
| 20 |
| 23 |
| EG001 | MK-0941 Titration 2 | Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin. | 1 | 24 | 21 | 24 |
| EG002 | Placebo Titration 1 | Participants receiving placebo while on basal insulin. | 0 | 12 | 11 | 12 |
| EG003 | Placebo Titration 2 | Participants receiving placebo while on basal insulin. | 1 | 11 | 10 | 11 |
| Vaginal Haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vessel Puncture Site Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Peripheral Coldness | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2
| ANOVA |
| <0.001 |
| Mean Difference (Final Values) |
| 50.28 |
| Standard Error of the Mean |
| 13.67 |
| 2-Sided |
| 90 |
| 27.68 |
| 72.88 |
| No |
| Superiority or Other |