A Comparison of Two Initial Dosing Formulas

Study Overview
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Brief Summary
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This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.

Detailed Description
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The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.

Official Title
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A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Age 18 years and above Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides A1c ≥ 7.0% but ≤ 10% Capable of self monitoring glucose ≥4/day Previously compliant with clinical recommendations Fasting blood glucose ≥ 150 mg/dl BMI ≤ 45 kg/m2 Exclusion Criteria: Urinary ketosis Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine >1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another) Currently participating in another clinical trial Known or suspected allergy to insulin determir Using insulin Pregnancy or nursing or the intention of becoming pregnant or not using adequate Significant liver or heart failure.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insulin determir<br> | Drug: Insulin detemir<br>* Subjects will be randomized to weight based method of 0.1 U/kg for basal insulin or a starting dose based upon an insulin challenge. Subject will record morning fasting blood sugar daily. Using a three day average, the subject will titrate the dose of basal insulin either increasing or lowering by three units based upon target blood glucose of 110 mg/dl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to reach the titration target | The number of days for the subject to reach the titration target blood sugar of 110 ml/dl | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal insulin, hypoglycemia, diabetes mellitus type two