Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Comparison of Two Initial Dosing Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allen B. King, MD, Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT01377155
First received: June 17, 2011
Last updated: August 23, 2013
Last verified: August 2013

June 17, 2011
August 23, 2013
June 2011
December 2011   (final data collection date for primary outcome measure)
Days to reach the titration target [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
The number of days for the subject to reach the titration target blood sugar of 110 ml/dl
Same as current
Complete list of historical versions of study NCT01377155 on ClinicalTrials.gov Archive Site
The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Comparison of Two Initial Dosing Formulas
A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
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.
Insulin determir
Intervention: Drug: Insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377155
DCC 03-11
No
Allen B. King, MD, Diabetes Care Center
Diabetes Care Center
Not Provided
Principal Investigator: Allen B King, MD Diabetes Care Center
Diabetes Care Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP