Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily … (NCT02068443) | Clinical Trial Compass
CompletedPhase 3
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
Japan374 participantsStarted 2014-02
Plain-language summary
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in addition to diet and exercise therapy.
Who can participate
Age range20 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has a diagnosis of type 2 diabetes mellitus.
✓. Has a hemoglobin A1c (HbA1c) (National glycohemoglobin standardization program \[NGSP\]) of ≥6.9% to \<10.5% at 8 weeks after the start of the screening period (Week -4).
✓. Has an HbA1c (NGSP) difference between 4 weeks after the start of the screening period (Week -8) and 8 weeks after the start of the screening period (Week -4) being within 10.0% (rounded off to the first decimal place) of the value at 4 weeks after the start of the screening period (Week -8).
✓. Has been on a certain diet therapy and exercise therapy (if any) during the screening period.
✓. Has been receiving alogliptin on a stable dose and regimen (after breakfast, 25 mg/day) during the screening period.
✓. In the opinion of investigator or subinvestigator, the participant is considered appropriate to receive a biguanide as an add-on to alogliptin, at the end of the screening period (Week 0).
✓. In the opinion of investigator or subinvestigator, the participant is unlikely to require changes in the dose of antihypertensive agents (including discontinuation and suspension) or an additional antihypertensive agent during the study.
✓. Is a male and female aged ≥20 years to \<75 years. Participants aged ≥65 years to \<75 years need to be considered eligible for the enrollment by the investigator or subinvestigator at the end of the screening period (Week 0) taking into consideration the cardiovascular disorders pulmonary function disorders, renal function, hepatic function, etc.
Exclusion criteria
✕
What they're measuring
1
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period
Timeframe: Baseline and End of Treatment (EOT) (Up to Week 24)
. Has received other antidiabetic drugs than alogliptin (including insulin preparations and glucagon-like peptidase-1 \[GLP-1\] analog preparations) during the screening period.
✕. Has clinical manifestations of hepatic impairment.
✕. Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal during the screening period.
✕. Has clinical manifestations of renal impairment, including mild impairment.
✕. Has a history of lactic acidosis.
✕. Has any cardiovascular disease including shock, heart failure, myocardial infarction and pulmonary embolism, any serious pulmonary function disorder, or any other condition predisposing him/her to hypoxemia.
✕. Has dehydration or gastrointestinal dysfunction such as diarrhea or vomiting, which may cause dehydrated state.
✕. Has malnutrition, starved state, hyposthenia, pituitary gland dysfunction or adrenal insufficiency.