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

Condition(s) targeted: Diabetes Mellitus

Intervention: Insulin Detemir (Drug); Insulin Glargine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of New Mexico

Official(s) and/or principal investigator(s):
Mark Burge, M.D., Principal Investigator, Affiliation: University of New Mexico, Department of Internal Medicine, Division of Endocrinology
Stephen Mitchell, D.O., Study Director, Affiliation: University of New Mexico, Department of Internal Medicine, Division of Endocrinology

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.

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

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

Primary outcome: Calories Consumed During Test Meal After a 24 Hour Fast.

Secondary outcome:

% Body Fat by Bioelectrical Impedance

Satiety Scales

24-hour Dietary Recall

Food Diary

Resting Energy Expenditure

Serum Satiety Factors

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).

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

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

Related publications:

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Drugdex System:Klasko RK: Detemir. Drugdex System. Thomson Micromedex, Greenwood Village, Colorado (2007).

Hermansen K, Davies M. Does insulin detemir have a role in reducing risk of insulin-associated weight gain? Diabetes Obes Metab. 2007 May;9(3):209-17. Review.

Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. Review.

Tahbaz F, Kreis I, Calvert D. An audit of diabetes control, dietary management and quality of life in adults with type 1 diabetes mellitus, and a comparison with nondiabetic subjects. J Hum Nutr Diet. 2006 Feb;19(1):3-11.

Cruz AF, Calle-Pascual AL; Diabetes and Nutrition Study Group, Spanish Diabetes Association. Diabetes Nutrition and Complications Trial: Trends in nutritional pattern between 1993 and 2000 and targets of diabetes treatment in a sample of Spanish people with diabetes. Diabetes Care. 2004 Apr;27(4):984-7.

Toeller M, Buyken AE, Heitkamp G, Cathelineau G, Ferriss B, Michel G; EURODIAB IDDM Complications Study Group. Nutrient intakes as predictors of body weight in European people with type 1 diabetes. Int J Obes Relat Metab Disord. 2001 Dec;25(12):1815-22.

Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. Review.

McDuffie JR, Riggs PA, Calis KA, Freedman RJ, Oral EA, DePaoli AM, Yanovski JA. Effects of exogenous leptin on satiety and satiation in patients with lipodystrophy and leptin insufficiency. J Clin Endocrinol Metab. 2004 Sep;89(9):4258-63.

Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48.

Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83.

Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. Epub 2007 Mar 22.

de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. Review.

Wynne K, Bloom SR. The role of oxyntomodulin and peptide tyrosine-tyrosine (PYY) in appetite control. Nat Clin Pract Endocrinol Metab. 2006 Nov;2(11):612-20. Review.

Starting date: April 2008
Last updated: September 6, 2011