Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

NCT ID: NCT01507311

Last Updated: 2017-01-24

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

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

1999-12-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC 90-1170

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

A single dose injected subcutaneously (under the skin)

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

A single dose injected subcutaneously (under the skin)

Interventions

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liraglutide

A single dose injected subcutaneously (under the skin)

Intervention Type DRUG

placebo

A single dose injected subcutaneously (under the skin)

Intervention Type DRUG

Other Intervention Names

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NNC 90-1170

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
* BMI (Body Mass Index) between 24 and 35 kg/m\^2 (both inclusive)
* Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
* Anti-GAD (glutamic acid decarboxylase) negative

Exclusion Criteria

* Known or suspected allergy to trial product or related products
* Receipt of any investigational drug within three months prior to this trial
* Recurrent severe hypoglycaemia as judged by the investigator
* Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
* Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
* with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
* Liver or renal disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Ã…rhus C, , Denmark

Site Status

Countries

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Denmark

References

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Juhl CB, Hollingdal M, Sturis J, Jakobsen G, Agerso H, Veldhuis J, Porksen N, Schmitz O. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes. 2002 Feb;51(2):424-9. doi: 10.2337/diabetes.51.2.424.

Reference Type RESULT
PMID: 11812750 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2211-1219

Identifier Type: -

Identifier Source: org_study_id

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