Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Alogliptin and Metformin: Alogliptin 12.5 mg, tablets, orally, od, Glipizide placebo-matching tablets, orally, od and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily)
Sponsors
Takeda Global Research Development Centre Europe Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Has a diagnosis of type 2 diabetes mellitus. 2.Must be inadequately controlled (inadequate glycemic control refers to HbA1c concentration between 7.0 and 9.0 %, inclusive)on a stable daily dose of greater than or equal to1500 mg (or documented maximum tolerated dose) of metformin for at least 2 months prior to Screening or must be inadequately controlled (as defined by an HbA1c 7.5 and 10 %, inclusive) on metformin less than 1500 mg without documented maximum tolerated dose. 3.No treatment with antidiabetic agents other than metformin for 2 months prior to Screening (for Schedule A)/Pre-Screening (for Schedule B). 4.Has body mass index within 23kg/m2 and 45kg/m2 unless the subject is Asian or of Asian descent, for whom the allowable body mass index will be greater than or equal to 20 kg/m2 and less than or equal to 35 kg/m2, inclusive. 5.Has fasting C-peptide concentration at least 0.8 ng/ mL. 6.If regularly using non-excluded medications, must be on a stable dose at least 4 wks prior to screening/ pre-screening. 7.Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant, lactating or intends to donate ova from Screening throughout the duration of the study. 8.Must be able and willing to monitor their blood glucose concentrations with a home monitor, and comply with protocol requirements including scheduled clinic appointments.
Exclusion criteria
Exclusion criteria: 1.Systolic blood pressure greater than or equals to 150 mmHg and/or diastolic pressure greater than or equals to 90 mmHg at screening visit. 2.Hemoglobin less than/equal to 12 g/dL for males and less than/equal to 10 g/dL for females at screening visit. 3.Alanine aminotransferase greater than 2.5 times the upper limit of normal at Screening Visit. 4.Serum creatinine less than or equal to 1.5 mg/dL for males and less than or equal to 1.4 mg/dL for females, or calculated creatinine clearance less than 60 L/min. 5.A history of cancer other than squamous or basal cell carcinoma of the skin that has not been in full remission for at least 5 yrs prior to screening. 6.A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to screening. 7.Treated for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 8.New York Heart Association Class III or IV heart failure regardless of therapy. 9.History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack within 3 months prior to screening. 10.History of any hemoglobinopathy that may affect determination of HbA1c. 11.Known history of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or Hepatitis C virus (HCV). 12.History of psychiatric disorder that will affect the subject?s ability to participate in the study. 13.Alcohol or substance abuse within 2 years prior to screening. 14.Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: 15.Any investigational drug within 30 days prior to screening. 16.Any investigational diabetic drug within 3 months prior to screening. 17.Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 mimetics classes within 90 days prior to Screening . 18.Subject is a study site employee or is an immediate family member of a study site employee who is involved in the study. 19.Prior treatment with alogliptin. 20.Treatment with Weight-loss drugs, or oral or systemically injected glucocorticoids (including intra-articular injection) within 3 months prior to randomization through the completion of the end-of-treatment/ early termination procedures. 21.Received an investigational antidiabetic drug within the 3 months prior to screening. 22.Has a history of hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4 drug, metformin or glipizide. 23.Has a documented history or concurrent signs of significant thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Glycosylated HemoglobinTimepoint: Week 52 or week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Body WeightTimepoint: Weeks 12, 26, 39, 52, 65, 78, 91 and 104;Change from baseline in Fasting Plasma GlucoseTimepoint: Weeks 2,4, 8,12, 16,20,26, 39, 52, 65, 78, 91 and 104;Change from baseline in Glycosylated HemoglobinTimepoint: Weeks 4,8,12,16,20,26,39,65,78 and 91;Incidence of Glycosylated Hemoglobin less than to 7.0%Timepoint: Weeks 26, 52, 78 and 104;Incidence of Glycosylated Hemoglobin less than or equal to 6.5%Timepoint: Weeks 26, 52, 78 and 104 | — |
Countries
Argentina, Australia, Canada, Chile, Dominican Republic, Germany, Guatemala, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Other, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Shubhangi Desai
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed