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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

April 14, 2008
September 6, 2011
April 2008
December 2010   (final data collection date for primary outcome measure)
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.
The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety after a fast while treated with insulin detemir compared to insulin glargine. [ Time Frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00659165 on ClinicalTrials.gov Archive Site
  • % 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).
  • bioelectrical impedance analysis [ Time Frame: Once during each hospital admission ] [ Designated as safety issue: No ]
  • subject responses on validated 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 ]
  • 24-hour dietary recall [ Time Frame: performed once during each hospital admission ] [ Designated as safety issue: No ]
  • 1 week food diary [ Time Frame: performed daily for each meal during the last week of treatment with each study insulin ] [ Designated as safety issue: No ]
  • resting energy expenditure on indirect calorimetry/metabolic cart measurement [ Time Frame: performed once during each hospital admission ] [ Designated as safety issue: No ]
  • serum values of centrally acting mediators of satiety(PYY, ghrelin, leptin). [ 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 ]
Not Provided
Not Provided
 
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Diabetes Mellitus
  • 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
  • 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
  • Experimental: 1
    Insulin Detemir
    Intervention: Drug: Insulin Detemir
  • Experimental: 2
    Insulin Glargine
    Intervention: Drug: Insulin Glargine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00659165
UNM HRRC # 08-043
No
University of New Mexico
University of New Mexico
Not Provided
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
University of New Mexico
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP