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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511185
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 90-1170
Drug: placebo
Other: No treatment given
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slope of the mean ISR vs mean glucose [ Designated as safety issue: No ]
  • AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval [ Designated as safety issue: No ]
  • Insulin Clearance [ Designated as safety issue: No ]
  • NNC 90-1 170 plasma concentration [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2001
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: NNC 90-1170
A single dose of 7.5 mcg/kg administered subcutaneously in random order
Drug: placebo
A single dose administered subcutaneously in random order
Placebo Comparator: Placebo Drug: NNC 90-1170
A single dose of 7.5 mcg/kg administered subcutaneously in random order
Drug: placebo
A single dose administered subcutaneously in random order
No Intervention: Healthy Other: No treatment given
No trial drug administered but a graded glucose infusion

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Accepts Healthy Volunteers:   No
Criteria

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 three 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 maximum 10 g/L
  • HbA1c at least 6%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511185

Locations
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Grethe Jakobsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511185     History of Changes
Other Study ID Numbers: NN2211-2063
Study First Received: January 12, 2012
Last Updated: January 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014