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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT01267448
• Date of registration: 27/12/2010
• Prospective Registration: Yes
• Primary sponsor: Cook County Health
• Public title: Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
• Scientific title: A Pilot Study of Outpatient Discharge Therapy With Saxagliptin + Metformin XR or Sulphonylurea for Recently Diagnosed Type 2 Diabetes Presenting With Severe Hyperglycemia
• Date of first enrolment: September 9, 2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01267448
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ambika Babu, MD,MS
• Affiliation: John H Stroger Hospital of Cook County

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2

Hyperglycemia

Intervention(s)

Drug: Glipizide XL

Drug: Metformin XR

Drug: Saxagliptin + Metformin XR

Primary Outcome(s)

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. [Time Frame: 12 weeks]

Secondary Outcome(s)

The number of fold increase in beta cell function in the 2 arms. [Time Frame: 12 weeks]

Percentage of patients with symptomatic hypoglycemia [Time Frame: 12 weeks]

Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms [Time Frame: 12 weeks]

To measure percentage compliance with medication in the two treatment arms. [Time Frame: 12 weeks]

Secondary ID(s)

IRB-10-182

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb