A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

NCT00457093 | Completed

• 1 other identifier: 06-07
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study that when studies using our method of dosing adjustments driven by continuous glucose monitoring and because of the less variable glycemic effect of insulin detemir, insulin detemir treated subjects will spend a significantly greater time in the glucose target range than insulin glargine.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; continuous glucose monitoring; basal insulin

Outcome Measures

Primary Outcomes (1)

• In the time period 2400 to 0600 hours (the Basal Period) when post-meal food is least likely to affect the glucose level, detect the mean percentage pf time the glucose level is between 70-119 mg/dL

Secondary Outcomes (1)

• Establish the mean percentage of time spent in the glucose ranges of 40-70 mg/dL, 120-179 mg/dL, 180-240 mg/dL and >240 mg/dL in the Basal Period and for the entire day, and the average glucose for the entire 24 hour period.

Interventions

glargine DRUG

detemir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• Currently on a basal insulin, that is, NPH, glargine or detemir
• Capable of self monitoring glucose \>4/day
• Previously complaint with clinical recommendations
• Subject may be on oral antiglycemic medications but no change in treatment is permitted during study.

You may not qualify if:

• Hb A1c \>9.0%
• Urinary ketosis
• Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine \>1.5 mg/dL) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
• Currently participating in another clinical trial
• Known or suspected allergy to insulin glargine or detemir
• Using other insulins, such as, bolus insulin or premixed insulin
• Sight or hearing impaired
• Pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.

Sponsors & Collaborators

• Diabetes Care Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Diabetes Care Center

Salinas, California, 93901, United States

Location

Related Publications (10)

• Russell-Jones, D. et al. Diabetologia 2002;45(Suppl. 2):A51

  BACKGROUND

• Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.

  PMID: 11679447 BACKGROUND

• Bode BW, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999 Dec;46(3):183-90. doi: 10.1016/s0168-8227(99)00113-8.

  PMID: 10624783 BACKGROUND

• Mastrototaro J. The MiniMed Continuous Glucose Monitoring System (CGMS). J Pediatr Endocrinol Metab. 1999;12 Suppl 3:751-8. No abstract available.

  PMID: 10626266 BACKGROUND

• Metzger M, Leibowitz G, Wainstein J, Glaser B, Raz I. Reproducibility of glucose measurements using the glucose sensor. Diabetes Care. 2002 Jul;25(7):1185-91. doi: 10.2337/diacare.25.7.1185.

  PMID: 12087017 BACKGROUND

• Gross TM, Mastrototaro JJ. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S19-26. doi: 10.1089/15209150050214087. No abstract available.

  PMID: 11469628 BACKGROUND

• Gross TM, Bode BW, Einhorn D, Kayne DM, Reed JH, White NH, Mastrototaro JJ. Performance evaluation of the MiniMed continuous glucose monitoring system during patient home use. Diabetes Technol Ther. 2000 Spring;2(1):49-56. doi: 10.1089/152091500316737.

  PMID: 11467320 BACKGROUND

• King AB, Armstrong D. A comparison of basal insulin delivery: continuous subcutaneous insulin infusion versus glargine. Diabetes Care. 2003 Apr;26(4):1322. doi: 10.2337/diacare.26.4.1322. No abstract available.

  PMID: 12663626 BACKGROUND

• King, AB, Armstrong, DU. Presentation at Diabetes Technology & Therapeutics Meeting, 2003, San Francisco

  BACKGROUND

• Heise, T et al. Diabetes 2003;52(Suppl.1):A121

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Allen B. King, MD

  Diabetes Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: November 18, 2010

Record last verified: 2007-04

Locations

US (1)