A Comparison of Two Initial Dosing Formulas

Diabetes Care Center

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377155

DCC 03-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Insulin determir

Other group

Treatment:

Drug: Insulin detemir