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

This study has been completed.

Sponsor:

Information provided by:

Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT00993720

First received: October 9, 2009

Last updated: January 20, 2011

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 9, 2009
Last Updated Date	January 20, 2011
Start Date ^ICMJE	October 2009
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 9, 2009)	insulin-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00993720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 9, 2009)	24-hours glucose profiles with and without treatment of Victoza [ Time Frame: three days ] [ Designated as safety issue: Yes ] risk of hypoglycemia during physical activity with and without Victoza [ Time Frame: one day ] [ Designated as safety issue: Yes ] gastric emptying rate during hypoglycemia with and without Victoza [ Time Frame: one day ] [ Designated as safety issue: Yes ] weight change from baseline, change in fructosamine from baseline [ Time Frame: four weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Official Title ^ICMJE	Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Brief Summary	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Drug: 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. 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. Other: continuous insulin therapy after optimal treatment with insulin, patients continue on insulin for four weeks
Study Arm (s)	Experimental: type 1 DM with betacell function: Liraglutide Intervention: Drug: Liraglutide Experimental: type 1 DM without betacell function: Liraglutide Intervention: Drug: Liraglutide No Intervention: type 1 DM without betacell function: Insulin Intervention: Other: continuous insulin therapy
Publications *	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. Epub 2011 May 18.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT00993720
Other Study ID Numbers ^ICMJE	2009-001930-80
Has Data Monitoring Committee	Yes
Responsible Party	Sten Madsbad, MD, chief physician, Hvidovre University Hospital
Study Sponsor ^ICMJE	Hvidovre University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hvidovre University Hospital
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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