Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabete... ((TI) and bedtime glargine insulin (G) (n...)

HOME >> MEDICINE >> TECHNOLOGY

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

Date:6/6/2009

(TI) and bedtime glargine insulin (G) (n=334) or premixed biaspart 70/30 insulin BID (BPA 70/30) twice-a-day (n=343). The primary endpoint was mean change from baseline to week 52 in A1C. Secondary objectives were proportion of subjects reaching specific A1C levels and treatment differences in postprandial plasma glucose (PPG), fasting plasma glucose (FPG), and weight.

A1C was reduced by -0.66% and -0.72% in the TI+G and BPA 70/30 groups, respectively, and the proportion of subjects achieving A1C <7.0% were comparable between treatments (22% vs 27%). One-hour PPG change from baseline after a meal challenge was significantly lower in the TI+G group (37 vs. 54 mg/dL; p<0.0001). TI+G produced significantly less weight gain (0.9 vs. 2.5 kg; p=0.0002) and significantly less mild/moderate (48 percent vs. 69 percent, p<0.001) and severe (4 percent vs. 10 percent, p=0.0066) hypoglycemia compared to the BPA 70/30 group. Mean changes from baseline to week 52 in pulmonary function tests were similar in the two groups.

Type 1 Study Design and Key Findings

In the second study, patients with type 1 diabetes (A1C 7.0% and </=11.0%) were randomized to a 52-week trial comparing AFRESA (n=301) with insulin aspart, a rapid acting analog (RAA) (n=288), both given at meals with insulin glargine, a long-acting analog (LAA). Pre-specified efficacy endpoints included change in A1C, 1-hour PPG, 2-hour PPG and FPG following a standard meal challenge, and body weight. Adverse events were monitored to compare safety profiles.

Reductions in A1C were comparable in both treatment groups with no significant differences in LAA doses in either group. FPG levels (-35.5 +/- 3.3 vs. -20.6 +/- 3.2, p=0.0012) and 1-hour PPG (20.9 +/- 4.79 vs. 40.5 +/- 4.56, CI=0.0022) values were significantly lower with AFRESA than with RAA. Patients in the AFRESA group lost weight (-0.5 +/- 0.3), while patients in the RAA group gained we
'/>"/>

0

GOOD

Page: 1 2 3 4
Related medicine technology :

1. Ethicon Endo-Surgery Studies Presented at DDW Demonstrate Potential of Pure NOTES Surgery With Companys Toolbox
2. Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients
3. New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer
4. VA Studies Advanced Prosthetic Arm
5. PARI Pharmas Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS
6. Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
7. AlphaVax Announces Promising Results in Melanoma Studies
8. Autism Studies Presented at Mid-Atlantic Research Consortium Meeting
9. New Studies Show Popular Heartburn Medications Moderate the Effect of Taking Widely Prescribed Heart Drug
10. New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
11. Affitech-Discovered Anti-PS Antibodies in Development by Peregrine Pharmaceuticals Show Excellent Functionality in Preclinical Studies

Post Your Comments:

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabete...((TI) and bedtime glargine insulin (G) (n...),Health