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.
|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|
- 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.
- % 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).
|Study Start Date:||April 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659165
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|
|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|