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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508923
• Other study ID #: NN2211-1332
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2012
• Last updated: January 23, 2017
• Start date: May 2001
• Est. completion date: February 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 fun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour glucose profiles after three fixed meals
Secondary	24-hour insulin profiles after three fixed meals
Secondary	First phase insulin and maximal insulin secretory capacity
Secondary	EGR (endogenous glucose release) expressed in mg/kg/min
Secondary	GNG (gluconeogenesis) expressed in mg/kg/min
Secondary	24-hour glucagon profiles after three fixed meals
Secondary	24-hour FFA (free fatty acids) profiles after three fixed meals
Secondary	4-hour paracetamol profiles after two fixed meals
Secondary	30-hour NNC 90-1170 profile
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk