A Comparison of Two Initial Dosing Formulas

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin detemir

• Registration Number: NCT01377155
• Lead Sponsor: Diabetes Care Center

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin determir	Insulin detemir	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period	12 weeks

Trial Locations

Locations (1)

Diabetes Care Center; 🇺🇸 Salinas, California, United States