Diabetes Mellitus, Type 2
Conditions
Keywords
basal insulin, hypoglycemia, diabetes mellitus type two
Brief summary
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
Detailed description
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.
Interventions
DRUGInsulin detemir
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.
Sponsors
Diabetes Care Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. Age 18 years and above 3. Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides 4. A1c ≥ 7.0% but ≤ 10% 5. Capable of self monitoring glucose ≥4/day 6. Previously compliant with clinical recommendations 7. Fasting blood glucose ≥ 150 mg/dl 8. BMI ≤ 45 kg/m2
Exclusion criteria
1. Urinary ketosis 2. 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) 3. Currently participating in another clinical trial 4. Known or suspected allergy to insulin determir 5. Using insulin 6. Pregnancy or nursing or the intention of becoming pregnant or not using adequate 7. Significant liver or heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to reach the titration target | 12 weeks | The number of days for the subject to reach the titration target blood sugar of 110 ml/dl |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period | 12 weeks |
Countries
United States
Outcome results
None listed