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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

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date May 23, 2011
Study Start Date  ICMJE July 2002
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
  • HbA1c
  • Hypoglycemic events
  • Nocturnal hypoglycemia
  • Mean glucose
  • Mean fasting glucose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00276393 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
  • Days of titration of basal insulin
  • Fear of hypoglycemia
  • Continuos glucose monitoring
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes
Official Title  ICMJE Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Drug: Basal insulin
Study Arms  ICMJE Not Provided
Publications * Kudva YC, Basu A, Jenkins GD, Pons GM, Quandt LL, Gebel JA, Vogelsang DA, Smith SA, Rizza RA, Isley WL. Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. Diabetes Care. 2005 Jan;28(1):10-4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 11, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00276393
Other Study ID Numbers  ICMJE 70-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yogish C. Kudva, M.B.B.S Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP