Effect of Liraglutide on Weight and Appetite in Obese Sub... | NCT01508949

Studies
Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes

NCT01508949

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Nov 2, 2023Actual

Enrollment

35Actual

Phase

Phase 2

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

Oct 2023

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

Jun 2001

Primary Completion Date

Mar 2002Actual

Completion Date

Mar 2002Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 9, 2012

First Posted Date

Jan 12, 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

Oct 31, 2023

Last Update Posted Date

Nov 2, 2023Actual

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 the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

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	Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously	NNC 90-1170

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in weight

Secondary Outcomes

Measure	Description	Time Frame
Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
Waist circumference
Spontaneous energy intake assessed in connection to the ad libitum lunch meal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
HbA1c for diet treated subjects 6.5-12%, both inclusive
HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
Body mass index (BMI) at least 27 kg/m^2
Euthyroid subjects
Fasting blood glucose 7-14 mmol/l

Exclusion Criteria:

Impaired liver function
Impaired renal function
Cardiac problems
Uncontrolled treated/untreated hypertension
Recurrent severe hypoglycaemia as judged by the Investigator
Known or suspected allergy to trial product or related products
Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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		Frederiksberg C		1958	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15277417	Result	Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. doi: 10.2337/diacare.27.8.1915.

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