Diabetes MellitusNCT00659165
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
A study testing Insulin Detemir and Insulin Glargine in people with Diabetes Mellitus, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Detemir and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this 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
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.
Read the 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).
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin Detemir, Insulin Glargine
- Keywords
- 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
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DetemirDrug
Also called Levemir
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 GlargineDrug
Also called Lantus
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Detemir | Experimental | Insulin Detemir Receives: Drug: Insulin Detemir |
| Insulin Glargine | Experimental | Insulin Glargine Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calories Consumed After Fast.
Total energy ingested following the 24 hour fast.
Measured: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Burge, M.D., Principal investigator, University of New Mexico, Department of Internal Medicine, Division of EndocrinologyStephen Mitchell, D.O., Study director, University of New Mexico, Department of Internal Medicine, Division of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659165
- Sponsor's protocol ID
- UNM HRRC # 08-043
- Status last verified
- Feb 2018
- First submitted
- 14 Apr 2008
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1016/s0889-8529(07)80006-5.
PubMed 17881330Drugdex 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.
PubMed 17391147Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. doi: 10.1677/joe.1.05866.
PubMed 15684339Tahbaz 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.
PubMed 16448469Cruz 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.
PubMed 15047660Toeller 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.
PubMed 11781763Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. doi: 10.1046/j.1464-5491.2002.00790.x.
PubMed 12147141McDuffie 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.
PubMed 15356018Flint 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.
PubMed 10702749Stunkard 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.
PubMed 3981480Pieber 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.
PubMed 17381500de 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.
PubMed 15159223Wynne 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.
PubMed 17082808
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00659165
- Acronym / sponsor ID
- UNM HRRC # 08-043
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, insulin dependent diabetes, diabetes mellitus, detemir, levemir, glargine, lantus, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 5 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Detemir | Experimental | Drug: Insulin DetemirInsulin Detemir |
| Insulin Glargine | Experimental | Drug: Insulin GlargineInsulin Glargine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin DetemirAlso: LevemirSubjects 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. | Drug | Insulin Detemir |
| Insulin GlargineAlso: LantusSubjects 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. | Drug | Insulin Glargine |
Primary outcome
Calories Consumed After Fast.
Time frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
Total energy ingested following the 24 hour fast.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17881330Bush 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.
- BackgroundDrugdex System:Klasko RK: Detemir. Drugdex System. Thomson Micromedex, Greenwood Village, Colorado (2007).
- Background: PubMed 17391147Hermansen 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.
- Background: PubMed 15684339Wynne K, Stanley S, McGowan B, Bloom S. Appetite control. J Endocrinol. 2005 Feb;184(2):291-318. doi: 10.1677/joe.1.05866.
- Background: PubMed 16448469Tahbaz 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.
- Background: PubMed 15047660Cruz 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.
- Background: PubMed 11781763Toeller 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.
- Background: PubMed 12147141Wilding JP. Neuropeptides and appetite control. Diabet Med. 2002 Aug;19(8):619-27. doi: 10.1046/j.1464-5491.2002.00790.x.
- Background: PubMed 15356018McDuffie 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.
- Background: PubMed 10702749Flint 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.
- Background: PubMed 3981480Stunkard 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.
- Background: PubMed 17381500Pieber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Burge, M.D. principal investigator
University of New Mexico, Department of Internal Medicine, Division of Endocrinology
Stephen Mitchell, D.O. study director
University of New Mexico, Department of Internal Medicine, Division of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Detemir and Insulin Glargine in people with Diabetes Mellitus, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calories Consumed After Fast. (time frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00659165, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.