Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

NCT ID: NCT01508923

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

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2002-02-28

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion 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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Treatment period 1

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

placebo

Intervention Type DRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Treatment period 2

Group Type PLACEBO_COMPARATOR

liraglutide

Intervention Type DRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

placebo

Intervention Type DRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Interventions

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liraglutide

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Intervention Type DRUG

placebo

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Intervention Type DRUG

Other Intervention Names

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NNC 90-1170

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
* Body Mass Index (BMI) maximum 35 kg/m\^2
* Fasting plasma glucose 7-15 mmol/l, both inclusive

Exclusion Criteria

* Impaired liver function
* Impaired renal function
* Anaemia
* Cardiac disease
* Uncontrolled treated/untreated hypertension
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
* Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
* Loss of more than 400 ml blood during the three months prior to study start
* Allergy to paracetamol
Minimum Eligible Age

18 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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Degn KB, Juhl CB, Sturis J, Jakobsen G, Brock B, Chandramouli V, Rungby J, Landau BR, Schmitz O. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004 May;53(5):1187-94. doi: 10.2337/diabetes.53.5.1187.

Reference Type RESULT
PMID: 15111485 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2211-1332

Identifier Type: -

Identifier Source: org_study_id

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