Type 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS) MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Alogliptin
Product Code: SYR-322
SYR110322
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Alogliptin
CAS Number: 850649-62-6
Current Sponsor code: SYR-322
SYR110322
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral us
SYR110322
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral
SYR110322
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral
Sponsors
Takeda Global Research & 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 years of age or older who have a diagnosis of T2DM, who either are receiving monotherapy or combination antidiabetic therapy (with the exception of a DPP-4 inhibitor or GLP-1 analogue) prior to Screening. 2. Subjects must meet the following HbA1c requirements based on the following baseline therapy: (please note that HbA1c can be repeated during Screening): • If a subject’s antidiabetic regimen includes oral monotherapy or oral combination therapy, the subject must have an HbA1c level between 6.5% and 11.0%, inclusive, at Screening. • If the subject’s antidiabetic regimen includes insulin, the subject must have an HbA1c level between 7% and 11%, inclusive, at Screening. 3. Subject has a history of ACS (acute MI or unstable angina requiring hospitalization as defined in Appendix E) within 15 to 90 days prior to randomization. 4. Female subjects of childbearing potential who are sexually active who 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 (hysterectomy, bilateral oophorectomy, tubal ligation) or who are postmenopausal (defined as at least 45 years and above and at least 1 year since last regular menses). 5. Subject or the subject’s legally acceptable representative is able and willing to provide written informed consent prior to the initiation of any study procedures. 6. The subject is capable of understanding and complying with 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 4500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900
Exclusion criteria
Exclusion criteria: Any subject who meets any of the following criteria will not qualify for entry into the study: 1. Subject has signs of or is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults. 2. Subject is currently receiving a GLP-1 analogue for glycemic control of T2DM at Screening. 3. Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening. 4. Subject has any hemodynamically unstable CV disorder including heart failure (NYHA Class 4), refractory angina, uncontrolled arrhythmias, critical valvular heart disease, and severe hypertension at Screening. 5. Subject has had an ACS event less than 15 days prior to randomization according to the definition outlined in Appendix E of protocol. 6. Subject is hospitalized at Baseline/Randomization Visit. Subjects who have been discharged from an acute hospital to a cardiac rehabilitation center or nursing home at Baseline/Randomization Visit are not excluded. 7. Subject has received dialysis within 14 days prior to Screening. 8. Subject has a history of infection with human immunodeficiency virus. 9. Subject has a history of alcohol or substance abuse within the 6 months prior to the Screening Visit. 10. Subject has received any investigational drug within the 30 days prior to the Screening Visit or has received an investigational antidiabetic drug within the 3 months prior to the Screening Visit. 11. Subject has any major illness or debility that, in the investigator’s opinion, prohibits the subject from participating in the study. 12. 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. 13. Subject is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin [hCG]) in females of childbearing potential), intends to become pregnant during the study, or is lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that no excess risk of composite MACE exists following treatment with alogliptin compared with placebo when given in combination with Standard of Care in subjects with T2DM and ACS. For purposes of this study, the primary MACE composite comprises CV death, nonfatal MI, and nonfatal stroke.;Secondary Objective: To demonstrate superiority of alogliptin versus placebo with respect to the primary MACE composite: CV death, nonfatal MI and nonfatal stroke. To evaluate time from randomization to the first occurrence of any event in the secondary MACE composite: CV death, nonfatal MI, nonfatal stroke, and urgent revascularization due to unstable angina.;Primary end point(s): The primary endpoint will be the time from randomization to the first occurrence of any event in the primary MACE (major adverse cardiac event) composite: - CV death. - Nonfatal MI. - Nonfatal stroke. ;Timepoint(s) of evaluation of this end point: A primary MACE composite event could occur at any time during the study, so there is no fixed timepoint for evaluation of an individual event. Unblinded analyses of accrued events will be performed at the intervals described in the protocol(section 13.1.4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint will be the time from randomization to the first occurrence of any event in the secondary MACE composite: - CV death. - Nonfatal MI. - Nonfatal stroke. - Urgent revascularization due to unstable angina.;Timepoint(s) of evaluation of this end point: A secondary MACE composite event could occur at any time during the study, so there is no fixed timepoint for evaluation of an individual event. Unblinded analyses of accrued events will be performed at the intervals described in the protocol(section 13.1.4) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactProgram Manager
Takeda Global Research & Development Centre (Europe) Ltd.
Outcome results
None listed