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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00659165
First received: April 14, 2008
Last updated: September 6, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Drug: Insulin Detemir
Drug: Insulin Glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official 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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Calories Consumed During Test Meal After a 24 Hour Fast. [ Time Frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks ] [ Designated as safety issue: No ]
    Total energy ingested following the 24 hour fast.


Secondary Outcome Measures:
  • % Body Fat by Bioelectrical Impedance [ Time Frame: Once during each hospital admission ] [ Designated as safety issue: No ]
  • Satiety Scales [ Time Frame: performed at 3 points in time during each hospital admission: immediately upon hospital admission, and then again at 12 hours and 24 hours. ] [ Designated as safety issue: No ]
    Collected at baseline, after 24 hours of fasting, and after eating.

  • 24-hour Dietary Recall [ Time Frame: performed once during each hospital admission ] [ Designated as safety issue: No ]
  • Food Diary [ Time Frame: performed daily for each meal during the last week of treatment with each study insulin ] [ Designated as safety issue: No ]
    Food diaries were kept at home for one week prior to admission.

  • Resting Energy Expenditure [ Time Frame: performed once during each hospital admission ] [ Designated as safety issue: No ]
    Determined by indirect calorimetry/metabolic cart measurement on the morning of inpatient admission.

  • Serum Satiety Factors [ Time Frame: measured at 3 points in time during each hospital admission: at admission, 10 minutes prior to study meal and 60 minutes following study meal ] [ Designated as safety issue: No ]
    Serum values of centrally acting mediators of satiety(Peptide YY, ghrelin, leptin).


Enrollment: 10
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 Name: Levemir
Experimental: 2
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 Name: Lantus

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659165

Locations
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00659165     History of Changes
Other Study ID Numbers: UNM HRRC # 08-043
Study First Received: April 14, 2008
Results First Received: January 19, 2011
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
diabetes
insulin dependent diabetes
diabetes mellitus
detemir
levemir
glargine
lantus
insulin
appetite
satiety
centrally acting mediators of satiety
three factor eating questionnaire
PYY
ghrelin
leptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014