NCT00659165

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 5, 2011

Completed
Last Updated

March 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

April 14, 2008

Results QC Date

January 19, 2011

Last Update Submit

February 22, 2018

Conditions

Diabetes Mellitus

Keywords

diabetesinsulin dependent diabetesdiabetes mellitusdetemirlevemirglarginelantusinsulinappetitesatietycentrally acting mediators of satietythree factor eating questionnairePYYghrelinleptin

Outcome Measures

Primary Outcomes (1)

  • Calories Consumed After Fast.

    Total energy ingested following the 24 hour fast.

    Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

Study Arms (2)

Insulin Detemir

EXPERIMENTAL

Insulin Detemir

Drug: Insulin Detemir

Insulin Glargine

EXPERIMENTAL

Insulin Glargine

Drug: Insulin Glargine

Interventions

Insulin DetemirDRUG

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.

Also known as: Levemir
Insulin Detemir
Insulin GlargineDRUG

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.

Also known as: Lantus
Insulin Glargine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (14)

  • 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.

    PMID: 17881330BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 17391147BACKGROUND

  • Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. doi: 10.1677/joe.1.05866.

    PMID: 15684339BACKGROUND

  • 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.

    PMID: 16448469BACKGROUND

  • 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.

    PMID: 15047660BACKGROUND

  • 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.

    PMID: 11781763BACKGROUND

  • Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. doi: 10.1046/j.1464-5491.2002.00790.x.

    PMID: 12147141BACKGROUND

  • 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.

    PMID: 15356018BACKGROUND

  • 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.

    PMID: 10702749BACKGROUND

  • 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.

    PMID: 3981480BACKGROUND

  • 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.

    PMID: 17381500BACKGROUND

  • 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.

    PMID: 15159223BACKGROUND

  • 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.

    PMID: 17082808BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Insulin Resistance

Interventions

Insulin DetemirInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Mark Burge
Organization
Univ NM
mburge@salud.unm.edu
505-272-4658

Study Officials

  • Mark Burge, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Stephen Mitchell, D.O.

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

March 22, 2018

Results First Posted

October 5, 2011

Record last verified: 2018-02

Locations

US(1)