Trial Outcomes & Findings for Detemir: Role in Type 1 Diabetes (NCT NCT00564395)

Last Updated: 2018-07-17

Results Overview

Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

0-48 hours post-dose

Results posted on

2018-07-17

Participant Flow

Eighteen participants were recruited for this trial. However, only 14 participants completed both study visits. Subjects were recruited from the clinics through fliers and online postings

One male subject dropped out because of a very active sports schedule and could not continue participation. Three subjects (two males and one female) had trouble with the Continuous Glucose Monitoring (CGM) tracing and, therefore, were excluded from the final analysis.

Participant milestones

Participant milestones
Measure	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.	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
First Intervention (10 Days) STARTED	9	9
First Intervention (10 Days) Received Intervention	7	7
First Intervention (10 Days) COMPLETED	7	7
First Intervention (10 Days) NOT COMPLETED	2	2
Second Intervention (10 Days) STARTED	7	7
Second Intervention (10 Days) COMPLETED	7	7
Second Intervention (10 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
First Intervention (10 Days) Withdrawal by Subject	1	0
First Intervention (10 Days) Trouble with the CGM tracing	1	2

Baseline Characteristics

Detemir: Role in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=18 Participants Participants who were randomized to receive either Insulin Detemir mixed with RAI subcutaneous injection twice daily or Insulin Detemir and RAI as separate subcutaneous injections, twice daily
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.8 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-48 hours post-dose

Outcome measures

Outcome measures
Measure	Insulin Detemir Mixed With RAI Injection n=14 Participants Participants who received Insulin Detemir mixed with RAI injection, twice daily as subcutaneous injection in either the first or last 10 days of the study.	Insulin Detemir and RAI Injection Separately n=14 Participants Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily in either the first or last 10 days of the study.
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 mmol*hr/L Standard Deviation 70	469 mmol*hr/L Standard Deviation 112

Adverse Events

Insulin Detemir Mixed With RAI Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Detemir and RAI Injection Separately

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rubina Heptulla

Children's Hospital at Montefiore

Phone: 718-920-7004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place