NCT00276393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

1.4 years

First QC Date

January 11, 2006

Last Update Submit

May 20, 2011

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (5)

  • HbA1c

  • Hypoglycemic events

  • Nocturnal hypoglycemia

  • Mean glucose

  • Mean fasting glucose

Secondary Outcomes (3)

  • Days of titration of basal insulin

  • Fear of hypoglycemia

  • Continuos glucose monitoring

Interventions

Basal insulinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 15616226RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yogish C. Kudva, M.B.B.S

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

July 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

US(1)