A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

Study Overview
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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.

Official Title
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A Double Blind, Randomized, Parallel, Cross-Over Comparision of Glycemic Control Achieved With Once a Day Insulin Glargine Versus Detemir in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: glargine
* Drug: detemir


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: glargine|nan|
|Drug: detemir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, continuous glucose monitoring, basal insulin