Clinical trial NCT00276393: Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes
Official title: Randomized Trial Comparing Insulin Glargine to Ultra-Lente Insulin in Type I Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
measure: Hypoglycemic events
measure: Nocturnal hypoglycemia
measure: Mean glucose
measure: Mean fasting glucose
Secondary outcomes:
measure: Days of titration of basal insulin
measure: Fear of hypoglycemia
measure: Continuos glucose monitoring
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogish C. Kudva, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2337/diacare.28.1.10.