Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

NCT ID: NCT00993720

Last Updated: 2011-01-21

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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type 1 DM with betacell function: Liraglutide

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.

type 1 DM without betacell function: Liraglutide

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.

type 1 DM without betacell function: Insulin

Group Type NO_INTERVENTION

continuous insulin therapy

Intervention Type OTHER

after optimal treatment with insulin, patients continue on insulin for four weeks

Interventions

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Liraglutide

after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.

Intervention Type DRUG

Liraglutide

after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.

Intervention Type DRUG

continuous insulin therapy

after optimal treatment with insulin, patients continue on insulin for four weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 18-50y,
* BMI 18-27,
* caucasian origin,
* type 1 diabetes diagnosed between age 5 and age 40,
* no known diabetes complications or cardiovascular diseases,
* no medication known to influence glucose homeostasis,
* no pregnancy

Exclusion Criteria

* diabetes complications,
* autonomous nerve dysfunction,
* anaemia,
* HbA1c \< 8.5% at screening,
* estimated by the investigator to be incapable of completing the trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463-8. doi: 10.2337/dc11-0096. Epub 2011 May 18.

Reference Type DERIVED
PMID: 21593296 (View on PubMed)

Other Identifiers

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2009-001930-80

Identifier Type: -

Identifier Source: org_study_id

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