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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507311
• Other study ID #: NN2211-1219
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2012
• Last updated: January 23, 2017
• Start date: September 1999
• Est. completion date: December 1999

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 1999
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
A single dose injected subcutaneously (under the skin)
• placebo
A single dose injected subcutaneously (under the skin)

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)

Juhl CB, Hollingdal M, Sturis J, Jakobsen G, Agersø H, Veldhuis J, Pørksen 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretory burst mass
Secondary	Insulin secretory pulse mass, amplitude, frequency and regularity
Secondary	Insulin secretion
Secondary	Glucagon response
Secondary	Gastric emptying rate
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk