Trial Outcomes & Findings for Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes (NCT NCT00659165)

NCT ID: NCT00659165

Last Updated: 2018-03-22

Results Overview

Total energy ingested following the 24 hour fast.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks
• Results posted on: 2018-03-22

Participant Flow

Sporadic Newspaper advertisement, Albuquerque Journal, July 2008-July 2010.

Three weeks of treatment with each insulin (glargine, detemir) in random order, double blind assignment. Doses of glargine and detemir were equivalent and were based upon existing long acting insulin doses. Doses were titrated up to achieve target fasting glucose < 150 mg/dl. Both long acting insulins were given once daily before breakfast.

Participant milestones

Measure	Insulin Detemir These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.	Insulin Glargine These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Insulin Detemir n=5 Participants These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.	Insulin Glargine n=5 Participants These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 14 • n=5 Participants	33 years STANDARD_DEVIATION 8 • n=7 Participants	35 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks

Total energy ingested following the 24 hour fast.

Outcome measures

Measure	Insulin Detemir n=10 Participants These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.	Insulin Glargine n=10 Participants These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Calories Consumed After Fast.	1418 kcal Standard Deviation 636	1357 kcal Standard Deviation 576

Adverse Events

Insulin Detemir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Glargine

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

Mark Burge

Univ NM

Phone: 505-272-4658

Email: mburge@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place