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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003478-19 | EudraCT Number |
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This 24-week study is a safety and efficacy comparison of MK-1293 and Lantusâ„¢ in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in participants treated with MK-1293 compared with that in participants treated with Lantusâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1293 | Experimental | MK-1293 administered subcutaneously once daily in the evening. |
|
| Lantusâ„¢ | Active Comparator | Lantusâ„¢ administered subcutaneously once daily in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1293 | Drug | MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Participant Hemoglobin A1C Level at Week 24 | A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications. | Baseline and Week 24 |
| Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24 | Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Participant Body Weight at Week 24 | Change from baseline in participant body weight at Week 24. | Baseline and Week 24 |
| Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29761615 | Derived | Hollander PA, Carofano WL, Lam RLH, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rendell MS, Home PD, Gallwitz B, Rosenstock J. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2229-2237. doi: 10.1111/dom.13363. Epub 2018 Jun 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-1293 | MK-1293 administered subcutaneously once daily. |
| FG001 | Lantusâ„¢ | Lantusâ„¢ administered subcutaneously once daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-1293 | MK-1293 administered subcutaneously once daily. |
| BG001 | Lantusâ„¢ | Lantusâ„¢ administered subcutaneously 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 Participant Hemoglobin A1C Level at Week 24 | A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percent A1C | Baseline and Week 24 |
|
Up to 26 weeks (including 2-week follow-up for serious adverse events)
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 | MK-1293 | MK-1293 administered subcutaneously once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | 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 |
|---|---|
| C000629534 | MK-1293 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Lantusâ„¢ | Drug | Lantusâ„¢ (insulin glargine [rDNA origin]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantusâ„¢ at 10 units daily. Participants taking insulin will initiate Lantusâ„¢ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantusâ„¢ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
|
|
| Prandial insulin | Drug | Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control. |
|
Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels \
| Up to 24 weeks |
| Percentage of Participants Experiencing an AE Over the 24-week Treatment Period | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE. | Up to 24 weeks |
| Daily Basal Insulin Dose (Units) at Week 24 | The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date. | Week 24 |
| Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24 | Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg). | Week 24 |
| Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24 | Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits. | Baseline and Week 24 |
| Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24 | 7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM. | Baseline and Week 24 |
| Percentage of Participants With Hemoglobin A1C <7% at Week 24 | Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24. | Week 24 |
| Percentage of Participants With Hemoglobin A1C <6.5% at Week 24 | Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24. | Week 24 |
| Lost to Follow-up |
|
| Non-compliance with study drug |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24 | Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Number | Percentage of participants | Up to 24 weeks |
|
|
|
|
| Secondary | Change From Baseline in Participant Body Weight at Week 24 | Change from baseline in participant body weight at Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Mean | Standard Deviation | kilograms | Baseline and Week 24 |
|
|
|
| Secondary | Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24 | Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels \ | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Up to 24 weeks |
|
|
|
|
| Secondary | Percentage of Participants Experiencing an AE Over the 24-week Treatment Period | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE. | All randomized participants who received at least one dose of study treatment. | Posted | Number | Percentage of participants | Up to 24 weeks |
|
|
|
|
| Secondary | Daily Basal Insulin Dose (Units) at Week 24 | The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units | Week 24 |
|
|
|
|
| Secondary | Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24 | Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg). | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units/kg | Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24 | Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24 | 7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Percentage of Participants With Hemoglobin A1C <7% at Week 24 | Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24. | The analysis population included all randomized, treated participants with a Week 24 A1C measurement. | Posted | Number | Percentage of participants | Week 24 |
|
|
|
|
| Secondary | Percentage of Participants With Hemoglobin A1C <6.5% at Week 24 | Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24. | The analysis population included all randomized, treated participants with a Week 24 A1C measurement. | Posted | Number | Percentage of participants | Week 24 |
|
|
|
|
| 13 |
| 263 |
| 147 |
| 263 |
| EG001 | Lantusâ„¢ | Lantusâ„¢ administered subcutaneously once daily. | 9 | 263 | 151 | 263 |
| Angina unstable | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Mitral valve disease mixed | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cerebral small vessel ischaemic disease | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | 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 |