Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00659165 |
Recruitment Status
:
Completed
First Posted
: April 16, 2008
Results First Posted
: October 5, 2011
Last Update Posted
: March 22, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Drug: Insulin Detemir Drug: Insulin Glargine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
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 Start Date : | April 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Insulin Detemir
Insulin Detemir
|
Drug: 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.
Other Name: Levemir
|
Experimental: Insulin Glargine
Insulin Glargine
|
Drug: 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 Name: Lantus
|
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659165
United States, New Mexico | |
University of New Mexico Health Sciences Center | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Mark Burge, M.D. | University of New Mexico, Department of Internal Medicine, Division of Endocrinology | |
Study Director: | Stephen Mitchell, D.O. | University of New Mexico, Department of Internal Medicine, Division of Endocrinology |
Publications:
Responsible Party: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00659165 History of Changes |
Other Study ID Numbers: |
UNM HRRC # 08-043 |
First Posted: | April 16, 2008 Key Record Dates |
Results First Posted: | October 5, 2011 |
Last Update Posted: | March 22, 2018 |
Last Verified: | February 2018 |
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 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin, Globin Zinc Insulin Insulin Glargine Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |