N/A
Completed N=10
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
Source: ClinicalTrials.gov NCT00659165 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Calories Consumed After Fast. — 1418; 1357 kcal
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calories Consumed After Fast. |
1418; 1357 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00659165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.