Detemir: Role in Type 1 Diabetes

NCT ID: NCT00564395

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-05-31

Brief 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.

Detailed 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)

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Detemir+RAI, then Insulin Detemir and RAI separately

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.

Group Type: EXPERIMENTAL

Insulin Detemir mixed with RAI injection

Intervention Type: DRUG

Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection

Insulin Detemir and RAI separately, then Insulin Detemir+RAI

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.

Group Type: ACTIVE_COMPARATOR

Insulin Detemir and RAI injection

Intervention Type: DRUG

Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection

Interventions

Insulin Detemir mixed with RAI injection

Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection

Intervention Type: DRUG

Insulin Detemir and RAI injection

Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rubina Heptulla

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rubina A Heptulla, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital Endocrine and Diabetes Clinic

Houston, Texas, United States

Countries

United States

References

Nguyen TM, Renukuntla VS, Heptulla RA. Mixing insulin aspart with detemir does not affect glucose excursion in children with type 1 diabetes. Diabetes Care. 2010 Aug;33(8):1750-2. doi: 10.2337/dc10-0169. Epub 2010 May 26.

Reference Type: BACKGROUND

PMID: 20504899 (View on PubMed)

Other Identifiers

H-16541

Identifier Type: -

Identifier Source: org_study_id