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Completed

NCT Number: NCT01377155

A Comparison of Two Initial Dosing Formulas

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Care Center

Salinas, California, 93901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

insulin detemir

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.

Primary outcomes

  1. Days to reach the titration target

    Time frame: 12 weeks

    The number of days for the subject to reach the titration target blood sugar of 110 ml/dl

Secondary outcomes

  1. The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Diabetes Care Center

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 21, 2011
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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