Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

NCT ID: NCT01628445

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-11-30

Brief Summary

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Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (\>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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liraglutide

liraglutide 1.8 mg injected once daily

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

liraglutide titrated to 1.8 mg sc daily

Placebo injection

Group Type PLACEBO_COMPARATOR

placebo injection

Intervention Type DRUG

placebo injected sc daily volume equal to active comparator

Interventions

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liraglutide

liraglutide titrated to 1.8 mg sc daily

Intervention Type DRUG

placebo injection

placebo injected sc daily volume equal to active comparator

Intervention Type DRUG

Other Intervention Names

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Victoza Placebo

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* BMI≤45 kg/m2
* A1c ≥7.5% and ≤10.5%

Exclusion Criteria

* type 1 diabetes
* symptoms of poorly controlled diabetes
* eGFR \<50 ml/min/1.73m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vincent Woo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent C Woo, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Mantioba

Locations

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Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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U1111-1126-3937

Identifier Type: -

Identifier Source: org_study_id

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