Back to results

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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

liraglutide

placebo

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC 90-1170

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin secretory burst mass

Secondary Outcome Measures

Insulin secretory pulse mass, amplitude, frequency and regularity

Insulin secretion

Glucagon response

Gastric emptying rate

Adverse events

Full Information

NCT ID

NCT01507311

First Posted

January 6, 2012

Last Updated

January 23, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01507311

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 1999 (undefined)

Primary Completion Date

December 1999 (Actual)

Study Completion Date

December 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC 90-1170

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

liraglutide

Other Intervention Name(s)

NNC 90-1170

Intervention Description

A single dose injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

A single dose injected subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

Insulin secretory burst mass

Secondary Outcome Measure Information:

Title

Insulin secretory pulse mass, amplitude, frequency and regularity

Title

Insulin secretion

Title

Glucagon response

Title

Gastric emptying rate

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Århus C

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

11812750

Citation

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.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

We'll reach out to this number within 24 hrs