None listed
Conditions
Interventions
Group 1 Type of group
Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥
60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥
Group 2 Type of group
Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • 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. • 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. • 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. • Female subjects of childbearing potential who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study. • 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. • The subject is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
Exclusion criteria
Exclusion criteria: • Subject has signs of or is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults. • Subject is currently receiving a GLP-1 analogue for glycemic control of T2DM at Screening. • Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening. • 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. • Subject has had an ACS event less than 15 days prior to randomization according to the definition outlined in Appendix E of protocol. • 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. • Subject has received dialysis within 14 days prior to Screening. • Subject has a history of infection with human immunodeficiency virus. • Subject has a history of alcohol or substance abuse within the 6 months prior to the Screening Visit. • 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. • Subject has any major illness or debility that, in the investigator’s opinion, prohibits the subject from participating in the study. • 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. • 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
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee. Measure:Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE) Timepoints:From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months). | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee. Measure:Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) Timepoints:From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months). | — |
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungaria, India, Israel, Italy, Japan, Jordan, Korea South, Kuwait, Latovia, Lithuania, Malasya, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kindgdom, United States
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed