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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014