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

January 25, 2017 updated by: Novo Nordisk A/S

NNC 90-1170 Mechanism of Action: A Double-blind, Randomized, Single-center, Placebo Controlled, Crossover Study to Examine Beta-cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0926
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: liraglutide
A single dose of 7.5 mcg/kg administered subcutaneously in random order
Other Names:
  • NNC 90-1170
Drug: placebo
A single dose administered subcutaneously in random order
Experimental: NNC 90-1170
Drug: liraglutide
A single dose of 7.5 mcg/kg administered subcutaneously in random order
Other Names:
  • NNC 90-1170
Drug: placebo
A single dose administered subcutaneously in random order
No Intervention: Healthy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Adverse events
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-2063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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