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| Sponsored by: |
Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00276393 |
Purpose
Patients with type 1 diabetes trained in multiple daily insulin injection were treated with two diffferent kinds of long acting insulin preparations. The two insulin preparations were glargine and ultralente insulin.
Patients were randomized to receive one of the two insulin preparations for the first 4 months followed by the second preparation for a further four months. Short acting insulin used was the same during both periods. We found that glargine insulin was better than ultralente insulin in our study.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Drug: Basal insulin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes |
| Estimated Enrollment: | 22 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | December 2003 |
Multiple daily insulin injection (MDI) programs are commonly accompanied by considerable glycemic variation and hypoglycemia. In order to determine whether use of insulin glargine as a basal insulin would result in comparable HbA1c with less glycemic variation and hypoglycemia than ultralente insulin, 22 individuals with type
1 diabetes, experienced with MDI, and a HbA1c of <7.8 % were randomized, to receive either glargine or ultralente as the basal insulin for 4-months. Aspart insulin was used as the prandial. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. Treatment with glargine resulted in lower mean HbA1c, less nocturnal variability , and less hypoglycemia primarily due to less daytime hypoglycemia (p=0.002). On the other hand, serious hypoglycemia and average glucose concentration measured with continuous glucose monitoring system (CGMS) did not differ. We conclude that, while use of either ultralente or glargine as a basal insulin can result in excellent glycemic control, treatment with glargine is associated with slightly but significantly lower HbA1C, with less nocturnal glycemic variability and less hypoglycemia.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Type 1 diabetes, HbA1c < 7.8%, who have had prior instruction in a complex insulin program, and presently using a MDI insulin program with basal insulin preparations of Glargine or Ultralente and Humalog as the short acting insulin, should be free of hepatorenal abnormalities and hypoglycemia unawareness; non-pregnant, and should be able to perform frequent self monitoring of blood glucose (SMBG) and accept the use of continuous glucose monitoring system (CGMS). They should also possess the skill and understanding of insulin dose adjustments and supplementation.
Contacts and Locations More Information
| Study ID Numbers: | 70-02, 1A4372 |
| Study First Received: | January 11, 2006 |
| Last Updated: | January 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00276393 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Insulin Insulin, Long-Acting |
Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |
