A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT00457093
First received: April 3, 2007
Last updated: November 17, 2010
Last verified: April 2007
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Drug: glargine
Drug: detemir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Parallel, Cross-Over Comparision of Glycemic Control Achieved With Once a Day Insulin Glargine Versus Detemir in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Diabetes Care Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 35
Study Start Date: October 2006
Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457093

Locations
United States, California
Diabetes Care Center
Salinas, California, United States, 93901
Sponsors and Collaborators
Diabetes Care Center
Novo Nordisk A/S
Investigators
Principal Investigator: Allen B. King, MD Diabetes Care Center
  More Information

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

ClinicalTrials.gov Identifier: NCT00457093     History of Changes
Other Study ID Numbers: 06-07
Study First Received: April 3, 2007
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Care Center:
Type 2 Diabetes
continuous glucose monitoring
basal insulin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014