Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
NCT ID: NCT00659165
Last Updated: 2018-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2008-04-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Insulin Detemir
Insulin Detemir
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.
Insulin Glargine
Insulin Glargine
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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University of New Mexico
OTHER
Responsible Party
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Principal Investigators
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Mark Burge, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico, Department of Internal Medicine, Division of Endocrinology
Stephen Mitchell, D.O.
Role: STUDY_DIRECTOR
University of New Mexico, Department of Internal Medicine, Division of Endocrinology
Locations
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Countries
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References
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Bush MA. Intensive diabetes therapy and body weight: focus on insulin detemir. Endocrinol Metab Clin North Am. 2007 Aug;36 Suppl 1:33-44. doi: 10.1016/s0889-8529(07)80006-5.
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. doi: 10.1111/j.1463-1326.2006.00665.x.
Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. doi: 10.1677/joe.1.05866.
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. doi: 10.1111/j.1365-277X.2006.00668.x.
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. doi: 10.2337/diacare.27.4.984. 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. doi: 10.1038/sj.ijo.0801816.
Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. doi: 10.1046/j.1464-5491.2002.00790.x.
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. doi: 10.1210/jc.2003-031868.
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. doi: 10.1038/sj.ijo.0801083.
Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
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. doi: 10.1111/j.1464-5491.2007.02113.x. 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. doi: 10.1093/ajcn/79.6.946.
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. doi: 10.1038/ncpendmet0318.
Other Identifiers
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UNM HRRC # 08-043
Identifier Type: -
Identifier Source: org_study_id
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