Status:
COMPLETED
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 Mellit...
Detailed Description
The drug being tested in this study is a fixed-dose combination tablet of alogliptin and metformin to treat people who have diabetes. This study will look at glycemic control in people who take alogli...
Eligibility Criteria
Inclusion
- Capable of understanding and complying with protocol requirements.
- 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.
- Has a historical diagnosis of Type 2 diabetes mellitus (T2DM).
- Male or female and aged 18 to 75 years, inclusive.
- Body mass index (BMI) between 20 and 45 kg/m\^2, inclusive.
- 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.
- 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).
- 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.
- 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.
- Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary.
Exclusion
- Participated in another clinical study within 90 days prior to Screening.
- Received any investigational compound within 30 days prior to Randomization.
- Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening.
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Chronic pancreatitis and/or history of acute pancreatitis.
- Systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at Screening.
- History of any hemoglobinopathy or diagnosis of chronic anemia.
- 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.)
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- 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.
- 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.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB).
- History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds.
- 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.)
- History of alcohol or substance abuse within 2 years prior to Screening.
- Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs).
- History of organ transplantation.
- 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.
- Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study.
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT01890122
Start Date
September 1 2013
End Date
October 1 2015
Last Update
November 28 2016
Active Locations (45)
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1
Beijing, Beijing Municipality, China
2
Fuzhou, Fujian, China
3
Xiamen, Fujian, China
4
Guangzhou, Guangdong, China