Phase 4
N=18
Detemir: Role in Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00564395 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections — 457; 469 mmol*hr/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Detemir mixed with RAI injection (Drug); Insulin Detemir and RAI injection (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections |
457; 469 | — |
Summary
Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.
Eligibility Criteria
Inclusion Criteria
- Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
- On insulin glargine for at least 3 months
- Age 10-25 years
- Not on medications that may affect glucose concentrations
- Hemoglobin A1C (HbA1C) of less than 9 %
- Body Mass Index (BMI) less than 95th % and more than 10th%
- Supportive family
Exclusion Criteria
- Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
- Unable to adhere to insulin regimen
- Positive urine pregnancy test
Data sourced from ClinicalTrials.gov (NCT00564395). 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.