Trial Outcomes & Findings for Liraglutide in Type 1 Diabetes (NCT NCT01722240)

NCT ID: NCT01722240

Last Updated: 2024-01-23

Results Overview

HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

69 participants

Primary outcome timeframe

52 Weeks

Results posted on

2024-01-23

Participant Flow

Exclusion Criteria: Type 1 diabetes for less than 6 months. Coronary event or procedure (myocardial infraction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. Hepatic disease (transamine \> 3 times normal) or cirrhosis. Renal impairment (serum eGFR \< 30 mL/min/1.73m2).

Participant milestones

Participant milestones
Measure	Liraglutide Liraglutide 1.8 mg Daily Injection	Placebo Daily placebo Injection Placebo
Overall Study STARTED	35	34
Overall Study COMPLETED	26	20
Overall Study NOT COMPLETED	9	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

male and female counted here as a separate category

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide 1.8mg n=29 Participants Daily Injection Liraglutide 1.8mg	Placebo n=27 Participants Daily Injection Placebo	Total n=56 Participants Total of all reporting groups
Age, Customized Age	45 years STANDARD_DEVIATION 2 • n=5 Participants	47 years STANDARD_DEVIATION 3 • n=7 Participants	46 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex/Gender, Customized Gender · male	12 Participants n=5 Participants • male and female counted here as a separate category	14 Participants n=7 Participants • male and female counted here as a separate category	26 Participants n=5 Participants • male and female counted here as a separate category
Sex/Gender, Customized Gender · female	17 Participants n=5 Participants • male and female counted here as a separate category	13 Participants n=7 Participants • male and female counted here as a separate category	30 Participants n=5 Participants • male and female counted here as a separate category
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
HbA1c (%)	7.92 percentage of hemoglobin STANDARD_DEVIATION 0.19 • n=5 Participants	7.50 percentage of hemoglobin STANDARD_DEVIATION 0.18 • n=7 Participants	7.71 percentage of hemoglobin STANDARD_DEVIATION 0.18 • n=5 Participants
Body Mass Index (BMI)	28.9 Kg/m2 STANDARD_DEVIATION 1.1 • n=5 Participants	29.1 Kg/m2 STANDARD_DEVIATION 1.6 • n=7 Participants	29.0 Kg/m2 STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 52 Weeks

HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.

Outcome measures

Outcome measures
Measure	Liraglutide n=26 Participants Daily Injection	Placebo n=20 Participants Daily Injection Placebo
HbA1c (%) week 0	7.92 Percent of Hemoglobin (%) Standard Error 0.15	7.48 Percent of Hemoglobin (%) Standard Error 0.18
HbA1c (%) week 52	7.45 Percent of Hemoglobin (%) Standard Error 0.12	7.58 Percent of Hemoglobin (%) Standard Error 0.14

SECONDARY outcome

Timeframe: 52 Weeks

Mean weekly glucose concentrations measured by CGM at baseline and at 52 weeks

Outcome measures

Outcome measures
Measure	Liraglutide n=26 Participants Daily Injection	Placebo n=20 Participants Daily Injection Placebo
Mean Weekly Glucose Concentrations. week 0	173 mg/dL Standard Error 5	160 mg/dL Standard Error 6
Mean Weekly Glucose Concentrations. week 52	156 mg/dL Standard Error 6	156 mg/dL Standard Error 6

SECONDARY outcome

Timeframe: 52 weeks

Body weight in Kg measured at weeks 0 (baseline) and at 52 weeks after treatment with liraglutide or placebo

Outcome measures

Outcome measures
Measure	Liraglutide n=26 Participants Daily Injection	Placebo n=20 Participants Daily Injection Placebo
Body Weight week 0	83.6 Kg Standard Error 3.8	84.1 Kg Standard Error 4.0
Body Weight week 52	80.5 Kg Standard Error 3.8	83.8 Kg Standard Error 4.0

Adverse Events

Liraglutide

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Dr. Paresh Dandona

Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA

Phone: 7169574325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place