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Trial Outcomes & Findings for 52 Week Trial of Liraglutide in Type 1 Diabetes (NCT NCT01787916)

NCT ID: NCT01787916

Last Updated: 2018-01-05

Results Overview

To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Measure changes in HbA1c at 24 and 52 weeks from baseline

Results posted on

2018-01-05

Participant Flow

Participant milestones

Participant milestones
Measure
Liraglutide First, Then Placebo
Liraglutide, s.c., 1.8 mg, die, 24 weeks First Intervention (24 weeks)", "Washout (4 weeks)", and "Second Intervention (24 weeks
Placebo First, the Liraglutide
subjects were submitted to placebo and liraglutide in a randomly manner
First Intervention (24 Weeks)
STARTED
8
7
First Intervention (24 Weeks)
COMPLETED
8
7
First Intervention (24 Weeks)
NOT COMPLETED
0
0
Washout (4 Weeks)
STARTED
8
7
Washout (4 Weeks)
COMPLETED
8
7
Washout (4 Weeks)
NOT COMPLETED
0
0
Second Intervention (24 Weeks)
STARTED
8
7
Second Intervention (24 Weeks)
COMPLETED
8
7
Second Intervention (24 Weeks)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

52 Week Trial of Liraglutide in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=15 Participants
Patients beginning with liraglutide will be switched to Placebo and vice versa
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
8 Participants
n=93 Participants
Sex: Female, Male
Male
7 Participants
n=93 Participants
Region of Enrollment
Canada
15 participants
n=93 Participants

PRIMARY outcome

Timeframe: Measure changes in HbA1c at 24 and 52 weeks from baseline

To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.

Outcome measures

Outcome measures
Measure
Liraglutide
n=15 Participants
Liraglutide, s.c., 1.8 mg, die, 24 weeks Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Placebo
n=15 Participants
Placebo visually identical to study drug will be given Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Assessment of Changes in Glycemic Control by HbA1c.
0.3 percentage of HbA1c
Standard Deviation 0.1
0.2 percentage of HbA1c
Standard Deviation 0.1

SECONDARY outcome

Timeframe: Measure changes in the composite at 24 and 52 weeks from baseline

To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue

Outcome measures

Outcome data not reported

Adverse Events

Liraglutide

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Liraglutide
n=15 participants at risk
Liraglutide, s.c., 1.8 mg, die, 24 weeks Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Placebo
n=15 participants at risk
Placebo visually identical to study drug will be given Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Gastrointestinal disorders
nausea
86.7%
13/15 • Number of events 13 • 1 yr
0.00%
0/15 • 1 yr

Additional Information

Weisnagel

CHU de Quebec

Phone: 4185254444

Results disclosure agreements

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

Restriction type: OTHER