NCT01508949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started Jun 2001

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in weight

Secondary Outcomes (8)

  • 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

  • Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))

  • Gastric emptying rate

  • +3 more secondary outcomes

Study Arms (2)

NNC 90-1170

EXPERIMENTAL
Drug: liraglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

liraglutideDRUG

Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

Also known as: NNC 90-1170
NNC 90-1170
placeboDRUG

Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 15277417RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 12, 2012

Study Start

June 1, 2001

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

DK(1)