A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes - NCT00457093-93901 (Clinical Trial 167543)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy167543.aspx
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| City: |
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Salinas |
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State:
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CA |
| Zip Code: |
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93901 |
| Conditions: |
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Type 2 Diabetes |
| Purpose: |
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The purpose of this study that when studies using our method of dosing adjustments driven by
continuous glucose monitoring and because of the less variable glycemic effect of insulin
detemir, insulin detemir treated subjects will spend a significantly greater time in the
glucose target range than insulin glargine.
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| Study summary: |
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Todate, most studies have compared insulin detemir and glargine to NPH and not to each
other. Depending of their design, these studies have shown both insulins lower the fasting
glucose, A1c, the incidence of hypoglycemia and are associated with less weight gain than
NPH. In the only direct comparison study of these two basal insulins, insulin detemir
demonstrated significantly less day to day variation than glargine as measured by glucose
infusion rated during an euglycemic clamp study. Given the same incidence of hypoglycemia,
this last study would suggest that insulin detemir treatment could achieve target glucose
control more than glargine. We have used continuous glucose monitoring (CGMS) extensively
in our practice. CGMS is arguably the most sensitive method for detecting differences in
glycemic control in the outpatient setting and there by allowing fine adjustments in insulin
treatment. When comparing insulin glargine to preprogrammable basal insulin as delivered by
continuous subcutaneous infusion and using CGMS, we have shown significantly better glucose
control with continuous subcutaneous infusion, We have also developed a method of daily
insulin dosage adjustments during a continuous CGMS study from daily glucose tracings
downloaded. This allows for an even more accurate basal insulin replacement per set
glycemic goal. This protocol addresses a comparison of insulin glargine and insulin detemir
for patients evaluated by CGMS. |
| Criteria: |
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Inclusion Criteria:
- Type 2 Diabetes
- Currently on a basal insulin, that is, NPH, glargine or detemir
- Capable of self monitoring glucose >4/day
- Previously complaint with clinical recommendations
- Subject may be on oral antiglycemic medications but no change in treatment is
permitted during study.
Exclusion Criteria:
- Hb A1c >9.0%
- Urinary ketosis
- Currently or expected alteration in insulin sensitivity such as major surgery,
infection, renal failure (creatine >1.5 mg/dL) glucocorticoid treatment, recent
(within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
- Currently participating in another clinical trial
- Known or suspected allergy to insulin glargine or detemir
- Using other insulins, such as, bolus insulin or premixed insulin
- Sight or hearing impaired
- Pregnancy oor nursing of the intention of becoming pregnant or not using adequate
contraceptive measures. |
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| Study is available at: |
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Diabetes Care Center
Salinas, CA 93901
United States
Primary Contact:
Allen B King, MD
Email: aking@diabetescarecenter.com
Phone: 831-769-9355
Secondary Contact:
Allen B King, MD
Email: aking@diabetescarecenter.com
Phone: 831-769-9355 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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