Type II Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: MK 524A (ER Niacin/MK-0524) or MK 0524 (ER-Niacin/Laropipant
Pharmaceutical Form: Tablet
INN or Proposed INN: MK 524 or L-000888839-00E or Laropiprant
Concentration unit: mg milligram(s)
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female and 18 to 80 years of age on day of signing informed consent. 2. Patient with a confirmed diagnosis of Type 2 Diabetes Mellitus. 3. Patient will maintain diet consistent with ADA dietary guidelines or similar glucose and cholesterol lowering diet for the duration of the study. 4. If patient is receiving statin therapy, they should be on a stable dose for at least 3 weeks prior to Visit 1 (Week -1). 5. Patient is on a stable dose of any antidiabetic pharmacotherapy (with the exception of ± 10 units of insulin) for 3 months prior to Visit 1 (Week -1). NOTE: Changes to antidiabetic medications will be permitted during the study. 6. LDL-C is 70 mg/dL at Visit 1 (Week -1). NOTE: One immediate retest is allowed for patient with LDL-C value that is >10% outside the protocol specified acceptable inclusion range. 7. A female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. NOTE: Female patients who have reached menopause*, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use of contraceptives. * Menopause is defined as ?43 years of age and (1) no menses for >1 year and follicle stimulating hormone (FSH) levels elevated into postmenopausal range (defined by central lab) OR (2) no menses for at least 3 years. NOTE: Patients on cyclical hormonal contraceptives are not eligible. However, continuous hormone replacement therapy for post-menopausal women or continuous hormonal contraceptives are allowed provided that the patient has been on a stable regimen for >6 weeks prior to visit 1 and agrees to remain on this regimen throughout the study. Continuous hormonal contraceptive is not considered as one of the two acceptable methods for birth control. 8. Triglyceride concentrations ?500 mg/dL at Visit 1 (Week-1). NOTE: One immediate retest is allowed for patient with TG value that is 15% outside acceptable inclusion range. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14 day post study follow-up. 2. Patient has a history of malignancy ?5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 3. Female patient is expecting to donate eggs during the study, including the 14 day follow-up. 4. Patient has a history of current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate. 5. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 6. Patient is currently participating in or has participated in a study with: - an investigational compound (non-lipid-modifying) within 30 days of Visit 1. - a lipid-modifying compound (investigational or marketed), within 6 weeks of Visit 1 (fibrate within 8 weeks) 7. Patient has taken torcetrapib alone or in combination and the last dose was within 1 year of Visit 1. 8. Patient has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study. 9. Patient has the following exclusionary laboratory values at Visit 1 (See Table 3-3 for retest guidance); Creatinine >2.0 mg/dL, ALT (SGPT) >1.5 x ULN, AST (SGOT) >1.5 x ULN, CK >2 xULN. 10. Patient has HbA1c at screening or Visit 1 >8.5% or is newly diagnosed with Type 2 Diabetes Mellitus (within 3 months of Visit 1). 11. Patient is at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse. 12. Patient currently engages, or during the study plans to engage, in vigorous exercise or an aggressive diet regimen. Prohibited Medical Conditions 13. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (ie: secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism. 14. Patient has nephrotic syndrome or other clinically significant renal disease. 15. Patient has chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV. 16. Patient has active peptic ulcer disease within 3 months of Visit 1. 17. Patient has had an episode of gout within 1 year of Visit 1, unless patient is taking allopurinol. 18. Patient has a history of hypersensitivity or allergic reaction to niacin or niacin- containing products. 19. Patient has uncontrolled/unstable cardiac arrhythmias. 20. Patient has history of myocardial infarction, stroke, coronary artery bypass surgery or other or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1. 21. Patient has unstable hypertension (sitting systolic blood pressure >160 mm Hg or diastolic >100 mm Hg) at Visit 1. Investigators are encouraged to maximize blood pressure control according to current local guidelines. 22. Patient has history of ileal bypass, gastric bypass or other significant condition associated with malabsorption. 23. Patient has active or chronic hepatobiliary or hepatic disease. 24. Patient is HIV positive. Prohibited Medications 25. Patient is on Cholestin™ within 6 weeks prior to Visit 2. 26. Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the LDL-C lowering efficacy of ER niacin/laropiprant (1 to 2g) compared with placebo in patients with Type 2 diabetes.;Secondary Objective: 1. In patients with Type 2 Diabetes, to assess: Percent change in HDL-C, Triglycerides (TG), TC/HDL-C ratio, LDL-C/HDL-C ratio, Apo B, Apo A-1. Safety and tolerability after 12 weeks of treatment with ER niacin/laropiprant (1 to 2g) compared to placebo. 2. In patients with Type 2 Diabetes, to assess change in HBA1c and FPG. Percent of patients requiring Anti-diabetic medication changes after 36 weeks of treatment with ER niacin/laropiprant (1 to 2g) compared to placebo. 3. In patients with Type 2 Diabetes, to assess change in HBA1c and FPG. Percent of patients requiring Anti-diabetic medication changes after 36 weeks of treatment with ER niacin/laropiprant (1 to 2g) compared to placebo. 4. In patients with Type 2 Diabetes, to perform a detailed lipoprotein analysis based on: A variety of Apoproteins (see Appendix 6.1) Beta-Quant parameters (see Appendix 6.1) VAP Quest Ion Mobility after 36 weeks of treatment with ER niacin/laropiprant (1 to 2g) compared to placebo. ;Primary end point(s): The primary efficacy endpoint is the percent change from baseline in LDL-C at Week 12. Secondary lipid endpoints are the percent change from baseline in HDL-C and other lipid parameters (except TG, hsCRP and Lp(a)) at Week 12. | — |
Countries
Belgium, Finland, Germany, Italy, Portugal, Sweden
Outcome results
None listed