Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia

Completed · Phase 4

Conditions studied: Diabetes Mellitus Type 2, Hyperglycemia

In brief

Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels 300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or occurrence of severe hypoglycemia compared to glipizide XL. The study may provide preliminary evidence to support the role of S+M as a bridging, stabilizing and safe therapy in patients with severe hyperglycemia

Key facts

Study ID

NCT01267448

Run by

Cook County Health

People needed

100

Starts

2014-09-09

Expected to finish

2015-07-25

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Target Population
• Subjects recently diagnosed with T2DM (less than 1 year duration) who are either drug naïve or who had not taken oral anti-diabetic agents or insulin for more than 2 weeks.
• FBG and or RBG > 300mg/dl and < 450mg/dl
• Age and Sex
• Men and women aged 18 to 75 years of age.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug to minimize the risk of pregnancy.
• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.

You may not qualify if…

• Sex and Reproductive Status
• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test.
• Sexually active fertile men not using effective birth control if their partners are WOCBP.
• Target Disease Exceptions
• Type 2 diabetes with weight less than 120 pounds
• Type 1 diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Medical History and Concurrent Diseases
• Age >75 years
• History of congestive heart failure
• Evidence of an impaired sensorium and/or dementia
• Current history of alcohol or substance abuse
• Patients with any acute or active chronic medical illness
• Physical and Laboratory Test Findings
• FBG and /or RGB < 300 mg/dl or >450 mg/dl
• Unstable vitals signs (temperature >101 degrees Fahrenheit, systolic blood pressure <90 or >180 mmhg, diastolic blood pressure <60 or >110 mmhg, heart rate <60 or >120 beats/minute)
• Electrolyte imbalances (serum bicarbonate level <20 mEq/L, serum sodium <125 or >150 mEq/L, serum potassium <3.5 or >5.5 mEq/L), serum creatinine more than 1.5 in males and 1.4 in females, creatinine clearance less than 60ml/min, liver enzymes 3 times above upper limit of normal range.
• HbA1c > 12% (based on our previous study (4) patients with HbA1c of >12 had a high rate of non-responders)
• Liver enzymes 3 times above upper limit of normal range.
• Allergies and Adverse Drug Reactions -Subjects with a history of any serious hypersensitivity reaction to saxagliptin, glipizide or metformin XR.
• Prohibited Treatments and/or Therapies
• a)Treatment with systemic cytochrome P450 3A4 (CYP 3A4) inhibitors.
• Other Exclusion Criteria

Where it is running

• John Stroger Hospital of Cook County — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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