Liraglutide as add-on to Insulin in Type 1 Diabetes

Summary

The purpose of this study is to:

Part 1:

To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

Part 2:

To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1

Interventions

DRUG

Liraglutide

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

DRUG

Placebo

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

DRUG

Liraglutide

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

DRUG

Placebo

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Sponsors & Collaborators

• NNF Center for Basal Metabolic Research, Denmark

  collaborator UNKNOWN

• Hillerod Hospital, Denmark

  collaborator OTHER

• Danish PhD schools of Molecular Metabolism and Endocrinology

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• Hvidovre University Hospital

  lead OTHER

Principal Investigators

• Christian SS Frandsen, MD · Hvidovre University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• Denmark

Study Locations