Trial · Interventional

CompletedPhase 2/3Registry data

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

NCTNCT00993720Other id2009-001930-80Other id2009

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 30 participants (actual)
Sponsor: Hvidovre University Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Oct 2009
Primary completion: Oct 2010
Completion: Oct 2010
First posted: 12 Oct 2009 (estimated)
Last update posted: 21 Jan 2011 (estimated)
Conditions: Diabetes Mellitus

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 2/3
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
NCT00993720
Oct 2009 to Oct 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
LiraglutideDrug
continuous insulin therapyOther

Arms3

Experimental
type 1 DM with betacell function: Liraglutide
Experimental
type 1 DM without betacell function: Liraglutide
No intervention
type 1 DM without betacell function: Insulin

Primary outcomes1

Outcomes the sponsor listed as primary.

insulin-dose
Time frame · 4 weeks

Secondary outcomes(4)

24-hours glucose profiles with and without treatment of Victoza
Time frame · three days
risk of hypoglycemia during physical activity with and without Victoza
Time frame · one day
gastric emptying rate during hypoglycemia with and without Victoza
Time frame · one day
weight change from baseline, change in fructosamine from baseline
Time frame · four weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

8 results

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.

Kielgast et al. 2011Diabetes carecited by 130

PMID 21593296PMC3120168DOI 10.2337/dc11-0096PUB-21593296

Free to read · publisher termsCC BY-NC-ND8 results

Read at source See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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