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Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276393
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : May 23, 2011
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Basal insulin Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes
Study Start Date : July 2002
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. HbA1c
  2. Hypoglycemic events
  3. Nocturnal hypoglycemia
  4. Mean glucose
  5. Mean fasting glucose

Secondary Outcome Measures :
  1. Days of titration of basal insulin
  2. Fear of hypoglycemia
  3. Continuos glucose monitoring

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276393

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Yogish C. Kudva, M.B.B.S Mayo Clinic

Publications of Results:
Layout table for additonal information Identifier: NCT00276393    
Other Study ID Numbers: 70-02
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs