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Completed

NCT Number: NCT00659165

Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn [NPH], glargine) except that it has been associated with less weight gain compared to other types of insulin. The reasons for this are still unclear. One possibility is that detemir insulin acts differently than do other insulins in affecting how diabetic patients eat meals. The purpose of this study is to determine whether appetite and calories eaten during a meal are affected by the type of insulin used to treat diabetes. This is a pilot study which means we are gathering preliminary information to determine if a larger study can be done.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

About this study

Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain that may allow for improved central nervous system activity and effects on satiety. The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine. Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY [PYY], ghrelin, leptin).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Treated with long-acting and meal time insulin therapy for at least 2 years
  • Ages 18 to 60 years of age
  • Glycosylated hemoglobin value between 7 - 9 mg/dL
  • C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.

Exclusion criteria

  • Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
  • Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
  • Pregnancy
  • Alcohol or drug abuse or dependence within three months of study entry
  • Less than 50 % agreement on 50-item Food Questionnaire with the Food Array "buffet style" study meal.
  • Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.

Treatment and study plan

insulin detemir

Drug

Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.

Other names: Levemir

insulin glargine

Drug

Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.

Other names: Lantus

Primary outcomes

  1. Calories Consumed After Fast.

    Time frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

    Total energy ingested following the 24 hour fast.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety and Calories Consumed in Type 1 Diabetes

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 16, 2008
Registry last updated
Mar 22, 2018

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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