Diabetes Mellitus | Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
Diabetes Mellitus research study
What is the primary objective of this study?
The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).
Who is eligible to participate?
Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Has a historical diagnosis of Type 2 diabetes mellitus (T2DM). 4. Male or female and aged 18 to 75 years, inclusive. 5. Body mass index (BMI) between 20 and 45 kg/m^2, inclusive. 6. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study. 7. Is experiencing inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) concentration between 7.5% and 10%, inclusive, and has been treated with diet and exercise for at least 2 months prior to Screening. (Exception: a participant who has received any other diabetic therapy for less than 7 days in total within the 2 months prior to the screening, can be included). 8. If male, has a hemoglobin >12 g/dL (>120 g/L) at Screening or if female, has a hemoglobin >10 g/dL (>100 g/L) at Screening. 9. If male, has a serum creatinine <1.5 mg/dL at Screening or if female, has a serum creatinine <1.4 mg/dL at Screening, and estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) at Screening. 10. Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary. Exclusion Criteria: 1. Participated in another clinical study within 90 days prior to Screening. 2. Received any investigational compound within 30 days prior to Randomization. 3. Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening. 4. History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. 5. History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 6. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 7. Chronic pancreatitis and/or history of acute pancreatitis. 8. Systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at Screening. 9. History of any hemoglobinopathy or diagnosis of chronic anemia. 10. New York Heart Association Class III or IV heart failure. (Participants who are stable at Class I or II and are currently treated, are candidates for the study.) 11. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening. 12. History of any cancer, other than squamous cell or basal cell carcinoma of the skin, which has not been in full remission for at least 5 years prior to Screening. Participants with a history of treated cervical intraepithelial neoplasia [CIN] I or CIN II are allowed. 13. Significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, human immunodeficiency virus or alanine aminotransferase (ALT) is 2.5 times above upper limit of normal value. 14. History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB). 15. History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds. 16. Has used oral or systemically injected glucocorticoids (including intra-articular injection) or has used weight-loss drugs within 2 months prior to Screening. (Inhaled or topical corticosteroids were allowed.) 17. History of alcohol or substance abuse within 2 years prior to Screening. 18. Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs). 19. History of organ transplantation. 20. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 21. Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study. 22. If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Metformin HClMetformin HCl capsules
Drug:Alogliptin and Metformin Fixed-Dose Combination (FDC)Alogliptin and metformin FDC tablets
Drug:Alogliptin PlaceboAlogliptin placebo-matching tablets
Drug:Metformin PlaceboMetformin placebo-matching capsules
Drug:Alogliptin and Metformin FDC PlaceboAlogliptin and metformin FDC placebo-matching tablets
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Metformin HCl 500 mgMetformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mgAlogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
Alogliptin 12.5 mg + Metformin HCl 500 mg FDCAlogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
PlaceboAlogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
Start Date: September 2013
Completed Date: October 2015
Phase: Phase 3
Primary Outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)
Secondary Outcome: Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Lead Sponsor: Takeda