Effect of Liraglutide on Pulsatile Insulin Secretion in S... | NCT01507311

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

NCT01507311

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 24, 2017Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

liraglutide
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Dec 1999Actual

Completion Date

Dec 1999Actual

First Submitted Date

Jan 6, 2012

First Submission Date that Met QC Criteria

Jan 6, 2012

First Posted Date

Jan 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC 90-1170	Experimental		Drug: liraglutide
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	A single dose injected subcutaneously (under the skin)	NNC 90-1170

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin secretory burst mass

Secondary Outcomes

Measure	Description	Time Frame
Insulin secretory pulse mass, amplitude, frequency and regularity
Insulin secretion
Glucagon response

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Århus C		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11812750	Result	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2