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A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

NCT ID: NCT00457093

Last Updated: 2010-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Todate, most studies have compared insulin detemir and glargine to NPH and not to each other. Depending of their design, these studies have shown both insulins lower the fasting glucose, A1c, the incidence of hypoglycemia and are associated with less weight gain than NPH. In the only direct comparison study of these two basal insulins, insulin detemir demonstrated significantly less day to day variation than glargine as measured by glucose infusion rated during an euglycemic clamp study. Given the same incidence of hypoglycemia, this last study would suggest that insulin detemir treatment could achieve target glucose control more than glargine. We have used continuous glucose monitoring (CGMS) extensively in our practice. CGMS is arguably the most sensitive method for detecting differences in glycemic control in the outpatient setting and there by allowing fine adjustments in insulin treatment. When comparing insulin glargine to preprogrammable basal insulin as delivered by continuous subcutaneous infusion and using CGMS, we have shown significantly better glucose control with continuous subcutaneous infusion, We have also developed a method of daily insulin dosage adjustments during a continuous CGMS study from daily glucose tracings downloaded. This allows for an even more accurate basal insulin replacement per set glycemic goal. This protocol addresses a comparison of insulin glargine and insulin detemir for patients evaluated by CGMS.

Conditions

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Type 2 Diabetes

Keywords

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Type 2 Diabetes continuous glucose monitoring basal insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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glargine

Intervention Type DRUG

detemir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Diabetes Care Center

INDUSTRY

Sponsor Role lead

Principal Investigators

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Allen B. King, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care Center

Locations

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Diabetes Care Center

Salinas, California, United States

Site Status

Countries

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United States

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11679447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10624783 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10626266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12087017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11469628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11467320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12663626 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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06-07

Identifier Type: -

Identifier Source: org_study_id