| Trial ID: | L2424 |
| Source ID: | NCT01267448
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| Associated Drug: |
Glipizide Xl
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| Title: |
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2|Hyperglycemia
|
| Interventions: |
DRUG: Glipizide XL|DRUG: Saxagliptin + Metformin XR|DRUG: Metformin XR
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| Outcome Measures: |
Primary: 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., Non-responder:1 FBG \>300 and/or PPBG \>400 mg/dl (week 1-6) and FBG \>250 and/or PPBG \>300 mg/dl in 4 consecutive readings or more (week 7-12). 2. A single confirmed BG of \>450 mg/dl. 3. Significant hypoglycemia: Single episode of hypoglycemia with BG \< 50 mg/dl or 2 episodes of BG between 50 and 70 mg/dl within 7 days or any episode of symptomatic hypoglycemia. 4. Persistently positive large ketones in urine and/or electrolyte imbalances. 5. Revisit to ED or admission to hospital because of hypoglycemia or uncontrolled hyperglycemia., 12 weeks | Secondary: Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms, The rate of decline in BG values (mg/dl) in the two groups over the period of twelve weeks will be analyzed using a mixed model (with random intercept) as a sensitivity analysis. The Kaplan-Meier (KM) curves, area under the curve,t-test and chi-square analysis will be used for analysis., 12 weeks|Percentage of patients with symptomatic hypoglycemia, Hypoglycemia and hospitalization rates will be compared between the 2 groups using either chi-square or Fisher exact test will be used. Binary logistic regression will be used to further analysis to identify predictors of hypoglycemia., 12 weeks|To measure percentage compliance with medication in the two treatment arms., Medication compliance will be assessed by pill counting. Each patient will assigned a percentage compliance and the study groups will be compared using independent two sample t-test., 12 weeks|The number of fold increase in beta cell function in the 2 arms., The early insulin response (EIR) will be calculated as the ratio of insulin to glucose response at 0 and 30 minutes (ΔI30pmol/l/ΔG30mmol/l,). The homeostasis model assessment to assess basal insulin secretion (HOMA-β cell) and insulin resistance (HOMA-IR) will be calculated. The beta cell response to OGTT will be calculated as area under the curve for glucose and insulin at 0, 30 and 60 minutes using the trapezoid rule., 12 weeks
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| Sponsor/Collaborators: |
Sponsor: Cook County Health | Collaborators: Bristol-Myers Squibb
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
100
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-09-09
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| Completion Date: |
2015-07-25
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| Results First Posted: |
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| Last Update Posted: |
2023-06-26
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| Locations: |
John Stroger Hospital of Cook County, Chicago, Illinois, 60612, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01267448
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