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
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Insulin detemir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Diabetes Care Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Insulin determir 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377155

Locations
United States, California
Diabetes Care Center
Salinas, California, United States, 93901
Sponsors and Collaborators
Diabetes Care Center
Investigators
Principal Investigator: Allen B King, MD Diabetes Care Center
  More Information

No publications provided

Responsible Party: Allen B. King, MD, Principal Investigator, Diabetes Care Center
ClinicalTrials.gov Identifier: NCT01377155     History of Changes
Other Study ID Numbers: DCC 03-11
Study First Received: June 17, 2011
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Care Center:
basal insulin
hypoglycemia
diabetes mellitus type two

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014