E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045261 |
E.1.2 | Term | Type IIa hyperlipidaemia |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective
To evaluate the LDL-C lowering efficacy of ER niacin/laropiprant (1 to 2 g) compared with placebo in patients with Type 2 diabetes. |
|
E.2.2 | Secondary objectives of the trial |
1. In patients with Type 2 Diabetes, to assess:
Percent change in HDL-C
Percent change in Triglycerides (TG)
Percent change in TC/HDL-C ratio
Percent change in LDL-C/HDL-C ratio
Percent change in Apo B
Percent change in Apo A-1
Safety and tolerability
after 12 weeks of treatment with ER niacin/laropiprant (1 to 2 g) compared to placebo.
2. In patients with Type 2 Diabetes, to assess the safety and tolerability after 36 weeks of treatment with ER niacin/laropiprant (1 to 2 g) compared to placebo.
3. In patients with Type 2 Diabetes, to assess:
Change in HbA1c
Change in FPG
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 οΎ± 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 <115 mg/dL and >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. |
|
E.4 | Principal exclusion criteria |
1. Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy 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.
NOTE: To participate in the study, patients who previously participated in a torcetrapib trial must provide documentation that he/she did not receive torcetrapib or that the last dose of torcetrapib was greater than 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 x ULN
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). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
LDL Changes respect to the basal value |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |