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A Comparison of Two Initial Dosing Formulas

NCT ID: NCT01377155

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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basal insulin hypoglycemia diabetes mellitus type two

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin determir

Group Type OTHER

Insulin detemir

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diabetes Care Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Allen B. King, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allen B King, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care Center

Locations

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Diabetes Care Center

Salinas, California, United States

Site Status

Countries

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United States

Other Identifiers

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DCC 03-11

Identifier Type: -

Identifier Source: org_study_id