A Comparison of Two Initial Dosing Formulas

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377155
• Other study ID #: DCC 03-11
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: August 23, 2013
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Diabetes Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin 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.

Locations

Country	Name	City	State
United States	Diabetes Care Center	Salinas	California

Sponsors (1)

Lead Sponsor	Collaborator
Diabetes Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period		12 weeks	Yes