Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0524A-069 | |||
| 2007_543 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. |
|
| 2 | Active Comparator | Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER niacin/laropiprant | Drug | One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo | After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo | Baseline and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo | After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo | Baseline and 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | MacLean A, McKenney J, Scott R, Brinton E, Bays H, Mitchel Y, Paolini J, Giezek H, Vandormael K, Ruck RA, Gibson K, Sisk CM, Maccubbin D. Efficacy and safety of extended release niacin/laropiprant in patients with type 2 diabetes mellitus. Br J Cardiol. 2011;18(1):37-45. | ||
| 25750540 | Derived | Bays HE, Brinton EA, Triscari J, Chen E, Maccubbin D, MacLean AA, Gibson KL, Ruck RA, Johnson-Levonas AO, O'Neill EA, Mitchel YB. Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control. Vasc Health Risk Manag. 2015 Feb 24;11:165-72. doi: 10.2147/VHRM.S70907. eCollection 2015. | |
| 22500948 |
Not provided
Not provided
Patients with Type 2 Diabetes who were not at protocol specified low-density lipoprotein cholesterol goal of <115 milligrams/deciliter at screening, had a 4-week run-in period of lipid modifying therapy. In order to advance to randomization, patients had to meet the low-density lipoprotein cholesterol goal.
First Patient In:13-Aug-2007, Last Patient Last Visit:15-Jan-2009
Ninety-four (94) sites participated: Australia 2 sites; Belgium 7 sites; Canada 6 sites; Ecuador 2 sites; Finland 2 sites; Germany 8 sites; Israel 4 sites; Italy 3 sites; Malaysia 5 sites; New Zealand 4 sites; Portugal 4 sites; Sweden 10 sites; Taiwan 5 sites; United States 32 sites
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Niacin/Laropiprant | One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram). No adjustments were made to any lipid modifying regimen established during run-in until Week 12. |
| FG001 | Placebo | Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Niacin/Laropiprant | One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram). No adjustments were made to any lipid modifying regimen established during run-in until Week 12. |
| BG001 |
| 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 | Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo | After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent change at Wk 12 compared to Bl | Baseline and 12 Weeks |
|
Not provided
7 randomized patients took no study drug dose and were not included in the safety follow-up
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Release Niacin/Laropiprant | One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram). No adjustments were made to any lipid modifying regimen established during run-in until Week 12. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C518174 | MK-0524 |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator : placebo (unspecified) | Drug | ER niacin/laropiprant Placebo |
|
| Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo |
after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo |
| Baseline and 12 Weeks |
| Derived |
| Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000. |
| 22400810 | Derived | Bays H, Giezek H, McKenney JM, O'Neill EA, Tershakovec AM. Extended-release niacin/laropiprant effects on lipoprotein subfractions in patients with type 2 diabetes mellitus. Metab Syndr Relat Disord. 2012 Aug;10(4):260-6. doi: 10.1089/met.2012.0005. Epub 2012 Mar 8. |
| 21401833 | Derived | Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Placebo |
Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Fasting Plasma Glucose | Mean | Standard Deviation | milligrams/deciliter |
|
| High-density lipoprotein cholesterol | Mean | Standard Deviation | milligrams/deciliter (mg/dl) |
|
| Low-density lipoprotein cholesterol | Mean | Standard Deviation | milligrams/deciliter (mg/dl) |
|
| Triglycerides | Median | Full Range | milligrams/deciliter (mg/dl) |
|
| Placebo |
Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study. |
|
|
|
| Secondary | Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo | After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Percent change at Wk 12 compared to Bl | Baseline and 12 Weeks |
|
|
|
|
| Secondary | Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo | after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo | Full Analysis Set With at Least one Post-Titration Visit Measurement | Posted | Median | 95% Confidence Interval | Percent change at Wk 12 compared to Bl | Baseline and 12 Weeks |
|
|
|
|
| 26 |
| 449 |
| 251 |
| 449 |
| EG001 | Placebo | Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study. | 24 | 340 | 113 | 340 |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Metastases to penis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004700 | Endocrine System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |