A Pilot Study of Outpatient Discharge Therapy With Saxagliptin + Metformin XR or Sulphonylurea for Recently Diagnosed Type 2 Diabetes Presenting With Severe Hyperglycemia

IRB-10-182

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

2014-09-09

2015-07-25

2015-07-25

Completed

Early phase I

100

Inclusion Criteria: 1. Target Population 1. 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. 2. FBG and or RBG \> 300mg/dl and \< 450mg/dl 2. Age and Sex 1. Men and women aged 18 to 75 years of age. 2. 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. Exclusion Criteria: 1. Sex and Reproductive Status 1. 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. 2. Women who are pregnant or breastfeeding. 3. Women with a positive pregnancy test. 4. Sexually active fertile men not using effective birth control if their partners are WOCBP. 2. Target Disease Exceptions 1. Type 2 diabetes with weight less than 120 pounds 2. Type 1 diabetes 3. History of diabetic ketoacidosis or hyperosmolar nonketotic coma 3. Medical History and Concurrent Diseases 1. Age \>75 years 2. History of congestive heart failure 3. Evidence of an impaired sensorium and/or dementia 4. Current history of alcohol or substance abuse 5. Patients with any acute or active chronic medical illness 4. Physical and Laboratory Test Findings 1. FBG and /or RGB \< 300 mg/dl or \>450 mg/dl 2. 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) 3. 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. 4. HbA1c \> 12% (based on our previous study (4) patients with HbA1c of \>12 had a high rate of non-responders) 5. Liver enzymes 3 times above upper limit of normal range. 6. Allergies and Adverse Drug Reactions -Subjects with a history of any serious hypersensitivity reaction to saxagliptin, glipizide or metformin XR. 5. Prohibited Treatments and/or Therapies a)Treatment with systemic cytochrome P450 3A4 (CYP 3A4) inhibitors. 6. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated. 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-06-26