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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01507311
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 1999-12
• Study Completion: 1999-12
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC 90-1170	liraglutide	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Insulin secretory burst mass

Secondary Outcome Measures

Name	Time	Method
Insulin secretion
Insulin secretory pulse mass, amplitude, frequency and regularity
Glucagon response
Gastric emptying rate
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Århus C, Denmark