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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01511185 (opens ClinicalTrials.gov in a new tab)Other idNN2211-2063
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
20 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Feb 2001
Primary completion
Oct 2001
Completion
Oct 2001
First posted
18 Jan 2012 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20012002
  1. Ph 1

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

    NCT01511185

    Feb 2001 to Oct 2001

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms3

  • Experimental

    NNC 90-1170

  • Placebo comparator

    Placebo

  • No intervention

    Healthy

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(5)

  1. Slope of the mean ISR vs mean glucose

  2. AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval

  3. Insulin Clearance

  4. NNC 90-1 170 plasma concentration

  5. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2003

6 results

The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose.

Chang et al. 2003Diabetescited by 157

PMID 12829647DOI 10.2337/diabetes.52.7.1786PUB-12829647

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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%

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