NCT01511185

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Feb 2001

Typical duration for phase_1 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

February 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 12, 2012

Last Update Submit

January 25, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

  • NNC 90-1 170 plasma concentration

  • Adverse events

Study Arms (3)

NNC 90-1170

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Placebo

PLACEBO COMPARATOR
Drug: liraglutideDrug: placebo

Healthy

NO INTERVENTION

Interventions

liraglutideDRUG

A single dose of 7.5 mcg/kg administered subcutaneously in random order

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

A single dose administered subcutaneously in random order

NNC 90-1170Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Ann Arbor, Michigan, 48109-0926, United States

Location

Related Publications (1)

  • 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.

    PMID: 12829647RESULT

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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

February 1, 2001

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

US(1)