Detemir: Role in Type 1 Diabetes

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Detemir and RAI injection; Drug: Insulin Detemir mixed with RAI injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00564395

H-16541

Details and patient eligibility

About

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.

Full description

One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence

This study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.

Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)

Enrollment: 18 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Insulin Detemir+RAI, then Insulin Detemir and RAI separately

Experimental group

Description:

Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.

Treatment:

Drug: Insulin Detemir mixed with RAI injection

Insulin Detemir and RAI separately, then Insulin Detemir+RAI

Active Comparator group

Description:

Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.

Treatment:

Drug: Insulin Detemir and RAI injection