Diabetes Mellitus Type 2 | Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
Diabetes Mellitus Type 2 research study
What is the primary objective of this study?
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
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Diabetes Mellitus Type 2
Severe Hyperglycemia - Blood Glucose Level >300mg/dl.
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:Glipizide XLThe control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.
Drug:Saxagliptin + Metformin XRThe intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.
Drug:Metformin XRThe intervention group will receive Metformin XR 1000 mg daily and will be automatically titrated weekly in 2 weeks to Metformin XR 2000 daily for a total duration of 12 weeks.
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.
Saxagliptin + Metformin XRSaxagliptin 5 mg + Metformin XR 1000 mg will be automatically titrated weekly in 2 weeks to Saxagliptin 5 mg + Metformin XR 2000 daily for a total duration of 12 weeks.
the Control goup Glipizide XLThe control group will receive Sulphonylurea (Glipizide XL 10mg orally) for a total duration of 12 weeks.
Start Date: December 2010
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: The proportion of responders in each arm. Responder: FBG 70-300 and/or PPBG <400 mg/dl (week1-6), FBG 70-250 and/or PPBG <300 mg/dl (week 7-12) and without metabolic exclusion criteria, repeat ED visits, hospitalization or significant hypoglycemia.
Secondary Outcome: Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms
Study sponsors, principal investigator, and references
Principal Investigator: Ambika Babu, MD,MS
Lead Sponsor: John H. Stroger Hospital
Collaborator: Bristol-Myers Squibb