Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00659165

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 (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: detemir insulin Drug: glargine insulin

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
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

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental detemir insulin	Drug: detemir insulin 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.
2: Experimental glargine insulin	Drug: glargine insulin 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.

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 (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

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

Contacts

Contact: Stephen M Mitchell, D.O.	(505) 272-4658	smitchell@salud.unm.edu
Contact: Mark Burge, M.D.	(505) 272-4658	mburge@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico Health Sciences Center, General Clinical Research Center	Recruiting
Albuquerque, New Mexico, United States, 87131-0001
Contact: Stephen Mitchell, D.O. 505-272-4658 smitchell@salud.unm.edu

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 og New Mexico, Department of Internal Medicine, Division of Endocrinology

More Information

Publications:

Bush MA. Intensive diabetes therapy and body weight: focus on insulin detemir. Endocrinol Metab Clin North Am. 2007 Aug;36 Suppl 1:33-44. Review.

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. No abstract available.

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.

Responsible Party:	University Of New Mexico, Department of Internal Medicine/Endocrinology ( Mark Burge, M.D. )
Study ID Numbers:	UNM HRRC # 08-043
Study First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659165 History of Changes
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

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Insulin
Body Weight

Insulin, Long-Acting
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Glargine
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009