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Completed

NCT Number: NCT01511185

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Ann Arbor, Michigan, 48109-0926, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

liraglutide

Drug

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

Other names: NNC 90-1170

Placebo

Drug

A single dose administered subcutaneously in random order

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jan 18, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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