Type II diabetes mellitus (T2DM) MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Alogliptin
Product Code: SYR-322
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Alogliptin
CAS Number: 850649-62-6
Current Sponsor code: SYR-322
Concentration unit: mg mill
Sponsors
Takeda Global Research and Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. Male or female subjects, 18 to 80 years of age, with a historical diagnosis of T2DM. 2. The subject has been treated with diet and exercise for at least 2 months prior to Screening and has an HbA1c concentration between 7.5% and 10.0%, inclusive at Screening. 3. The subject has received less than 7 days of any antidiabetic medication within 2 months prior to Screening. 4. Body mass index (BMI) =23 kg/m2 and =45 kg/m2 (except for Asian or Asian descendant subjects for whom the range is between 20 and 35 kg/ m2, inclusive). 5. Fasting C-peptide concentration =0.8 ng/mL (=0.26 nmol/L). 6. Subjects regularly using other, nonexcluded, medications must be on a stable dose for at least the 4 weeks prior to Screening; however, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator. 7. A female subject of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study. NOTE: Women NOT of childbearing potential are defined as those who have been surgically sterilized (ie, hysterectomy, bilateral salpingo-oophorectomy, bilateral tubal ligation) or who are postmenopausal (defined as at least 45 years of age AND 1 year since last regular menses). Acceptable methods of contraception are defined in Section 9.1.12 of the Protocol. 8. Subject is able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete subject diaries. 9. Subject is able and willing to provide written informed consent. 10. The subject is capable of understanding and complying with the protocol requirements, including scheduled clinic appointments. 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 710 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: 1. Hemoglobin =12 g/dL (=120 gm/L) for males and =10 g/dL (=100 gm/L) for females at Screening Visit. 2. Subject has a history of any hemoglobinopathy that may affect determination of HbA1c. 3. Subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. 4. Subject has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 5. Subject has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 6. Subject has systolic blood pressure =150 mmHg and /or diastolic pressure ?90 mmHg at Screening visit. 7. Subject has New York Heart Association (NYHA) Class III to IV heart failure (See Appendix E) regardless of therapy. (Currently treated subjects who are stable at NYHA Class I or II are candidates for the study.) 8. Subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening. 9. Alanine aminotransferase (ALT) >3x upper limit of normal at Screening. 10. Subject has a history of alcohol or substance abuse with the 2 years prior to Screening. 11. Serum creatinine = 1.5 mg/dL for males or =1.4 mg/dL for females, or creatinine clearance <60 mL/min based on calculation by central lab using the MDRD approximation at Screening. 12. Subject has history of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia [CIN] I or CIN II is allowed). 13. Subject has a history of infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus. 14. Subject has any major illness or debility that in the investigator’s opinion prohibits the subject from completing the study. 15. Subject has received any investigational drug within the 90 days prior to Screening. 16. Subject has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin, or related compounds. 17. If female, the subject is pregnant or lactating or intending to become pregnant during or within 1 month after participating in this study. Subject has used oral or systemically injected glucocorticoids (including intra-articular injection) or use of weight-loss drugs within 2 months prior to screening. (Inhaled or topical corticosteroids are allowed.) 18. The subject is unable to understand verbal or written English, or any other language for which a certified translation of the approved informed consent is available. 19. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, and sibling) of a study site employee who is involved in conduct of this study. 20. Subject has used oral or systemically injected glucocorticoids (including intra-articular injection) or use of weight-loss drugs within 2 months prior to screening. (Inhaled or topical corticosteroids are allowed.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of combination of alogliptin BID plus metformin BID as compared with alogliptin BID alone or metformin BID alone on HbA1c change from Baseline at Week 26 (or at time of discontinuation of double-blind study medication or hyperglycemic rescue).;Secondary Objective: - To evaluate the efficacy comparison between alogliptin BID alone and alogliptin QD alone on HbA1c change from Baseline at Week 26. - To evaluate other measures of glycemic control including change from Baseline of fasting plasma glucose at all visits, and HbA1c at visits other than Week 26. Safety objective: To evaluate the safety by adverse events, hypoglycemic events, clinical laboratory parameters, ECG readings, physical examination, and vital signs.;Primary end point(s): HbA1c change from Baseline at Week 26.;Timepoint(s) of evaluation of this end point: Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20. Change from Baseline in fasting plasma glucose at Weeks 1, 2, 4, 8, 12, 16, 20, and 26.;Timepoint(s) of evaluation of this end point: Change from Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20. Change from Baseline in fasting plasma glucose at Weeks 1, 2, 4, 8, 12, 16, 20, and 26. | — |
Countries
Czech Republic, Hungary, India, Israel, Lithuania, Mexico, Poland, Romania, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactDavid Brummell
PPD
Outcome results
None listed