A Comparison of Two Initial Dosing Formulas
1 other identifier
interventional
20
1 country
1
Brief Summary
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jun 2011
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 27, 2013
August 1, 2013
6 months
June 17, 2011
August 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period
12 weeks
Study Arms (1)
Insulin determir
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Age 18 years and above
- Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
- A1c ≥ 7.0% but ≤ 10%
- Capable of self monitoring glucose ≥4/day
- Previously compliant with clinical recommendations
- Fasting blood glucose ≥ 150 mg/dl
- BMI ≤ 45 kg/m2
You may not qualify if:
- Urinary ketosis
- 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)
- Currently participating in another clinical trial
- Known or suspected allergy to insulin determir
- Using insulin
- Pregnancy or nursing or the intention of becoming pregnant or not using adequate
- Significant liver or heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Care Center
Salinas, California, 93901, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allen B King, MD
Diabetes Care Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 21, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 27, 2013
Record last verified: 2013-08