Trial Outcomes & Findings for Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD) (NCT NCT00639626)

NCT ID: NCT00639626

Last Updated: 2018-04-12

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

6 months

Results posted on

2018-04-12

Participant Flow

PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Participant milestones

Participant milestones
Measure
Levemir
insulin detemir \[rDNA origin\] injection: Starting dose of 0.1-0.3 units/kg/day in a once daily subcutaneous injection.
Overall Study
STARTED
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 months

Population: PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.

Outcome measures

Outcome data not reported

Adverse Events

Levemir

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

Julie Rice, RN

Nationwide Children's Hospital

Phone: 6143553142

Results disclosure agreements

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