None listed
Conditions
Interventions
Group 1 Type of group
Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
Group name:Group 2 Type of group
Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
65 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Has a diagnosis of type 2 diabetes mellitus with either: Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening. • Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2. • If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. • Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. • Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. • No major illness or debility that in the investigator´s opinion prohibits the participant from completing the study.
Exclusion criteria
Exclusion criteria: • Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg. • Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females. • Alanine aminotransferase greater than or equal to 3 times the upper limit of normal. • Calculated creatinine clearance less than or equal to 50 mL/min. • Thyroid-stimulating hormone level outside of the normal range. • 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. • History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. • History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery. • New York Heart Association Class III or IV heart failure regardless of therapy. • History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening. • History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. • History of infection with Human Immunodeficiency Virus. • History of a psychiatric disorder that will affect the participant´s ability to participate in the study. • History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. • History of alcohol or substance abuse within the 2 years prior to Screening. • History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening. • Receipt of any investigational drug within the 30 days prior to Screening. • Prior treatment in an investigational study of alogliptin. • Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study. • Has donated more than 400 mL of blood within the 90 days preceding their participation in the study. • Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline. Measure:Change From Baseline in Glycosylated Hemoglobin at Week 52 Timepoints:Baseline and Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline. Measure:Change From Baseline in Glycosylated Hemoglobin Timepoints:Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42. ; Outcome name:Percentage of participants with at least one hypoglycemic episode during 52 week study. Measure:Incidence of Hypoglycemia Timepoints:up to 52 weeks ; Outcome name:The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study. Measure:Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL) Timepoints:On Occurrence (up to 52 weeks) ; Outcome name:The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study. Measure:Incidence of Hyperglycemic Rescue Timepoints:On Occurrence (up to 52 weeks). ; Outcome name:The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline. Measure:Change From Baseline in Fasting Plasma Glucose Timepoints:Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52. ; Outcome name:The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink. Measure:Change From Baseline in 2-hour Postprandial Glucose Timepoints:Baseline and Week 52 ; Outcome name:The change between the value of fasting proinsulin collected at each week indicated including final visit relative to base | — |
Countries
Hungary, India, Israel, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Taiwan, Ukraine, United States
Outcome results
None listed