Trial Outcomes & Findings for Liraglutide In Overweight Patients With Type 1 Diabetes (NCT NCT01753362)

NCT ID: NCT01753362

Last Updated: 2019-12-17

Results Overview

The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2019-12-17

Participant Flow

Participant milestones

Measure	Placebo subcutaneous daily injection placebo	Liraglutide subcutaneous daily injection liraglutide
Overall Study STARTED	36	48
Overall Study COMPLETED	26	40
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liraglutide In Overweight Patients With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=26 Participants subcutaneous daily injection placebo	Liraglutide n=40 Participants subcutaneous daily injection liraglutide	Total n=66 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	22 Participants n=5 Participants	36 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 14.6 • n=5 Participants	47 years STANDARD_DEVIATION 13.0 • n=7 Participants	47 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	26 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
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	0 Participants n=7 Participants	0 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	23 Participants n=5 Participants	38 Participants n=7 Participants	61 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	40 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.

Outcome measures

Measure	Placebo n=26 Participants subcutaneous daily injection placebo	Liraglutide n=40 Participants subcutaneous daily injection liraglutide
HbA1c baseline	7.77 percent Standard Deviation 0.83	7.94 percent Standard Deviation 1.05
HbA1c 26 week	7.64 percent Standard Deviation 0.84	7.60 percent Standard Deviation 0.98

SECONDARY outcome

Timeframe: 26 weeks

Mean daily glucose concentrations at baseline and 26 weeks

Outcome measures

Measure	Placebo n=26 Participants subcutaneous daily injection placebo	Liraglutide n=40 Participants subcutaneous daily injection liraglutide
Glucose Concentrations baseline	183 mg/dL Standard Deviation 6	173 mg/dL Standard Deviation 8
Glucose Concentrations 26 week	172 mg/dL Standard Deviation 5	171 mg/dL Standard Deviation 9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liraglutide

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

University at Buffalo

Phone: 716-535-1850

Email: dandona@buffalo.edu

Results disclosure agreements

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