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

February 22, 2018 updated by: University of New Mexico

Exploration of the Weight Neutral Effects of Insulin Detemir Compared to Insulin Glargine: A Measure of Satiety 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin Detemir
Drug: Insulin Detemir
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
Experimental: Insulin Glargine
Drug: Insulin Glargine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Mark Burge, M.D., University of New Mexico, Department of Internal Medicine, Division of Endocrinology
  • Study Director: Stephen Mitchell, D.O., University of New Mexico, Department of Internal Medicine, Division of Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNM HRRC # 08-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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