Effect of Liraglutide on the Beta-cell Responsiveness in... | NCT01511185

Studies
Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

NCT01511185

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 26, 2017Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

liraglutide
placebo

Countries

United States

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

Feb 2001

Primary Completion Date

Oct 2001Actual

Completion Date

Oct 2001Actual

First Submitted Date

Jan 12, 2012

First Submission Date that Met QC Criteria

Jan 17, 2012

First Posted Date

Jan 18, 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 25, 2017

Last Update Posted Date

Jan 26, 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 the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations 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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
NNC 90-1170	Experimental	Drug: liraglutide Drug: placebo
Placebo	Placebo Comparator	Drug: liraglutide Drug: placebo
Healthy	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	A single dose of 7.5 mcg/kg administered subcutaneously in random order	NNC 90-1170 Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval

Secondary Outcomes

Measure	Description	Time Frame
Slope of the mean ISR vs mean glucose
AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
Insulin Clearance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
Body Mass Index (BMI): 24-35 kg/m^2 inclusive

Exclusion Criteria:

SUBJECTS WITH TYPE 2 DIABETES
Receipt of any investigational drug within three months prior to this trial
Recurrent severe hypoglycemia as judged by the investigator
Cardiac disease
Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
Haemoglobin maximum 10 g/L
HbA1c above 12%
Loss of more than 400 mL blood during the 3 months prior to trial start
HEALTHY SUBJECTS
Receipt of any investigational drug within 3 months prior to this trial
Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
Use of any drug that in the investigator's opinion could interfere with the blood glucose level
Haemoglobin max. 10 g/L
HbA1c at least 6%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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		Ann Arbor	Michigan	48109-0926	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12829647	Result	Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B, Galecki A, Halter JB. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003 Jul;52(7):1786-91. doi: 10.2337/diabetes.52.7.1786.

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