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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511185
• Other study ID #: NN2211-2063
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: January 25, 2017
• Start date: February 2001
• Est. completion date: October 2001

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
A single dose of 7.5 mcg/kg administered subcutaneously in random order
• placebo
A single dose administered subcutaneously in random order

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang AM, Jakobsen G, Sturis J, Smith MJ, Bloem CJ, An B, Galecki A, Halter JB. The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003 Jul;52(7):1786-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
Secondary	Slope of the mean ISR vs mean glucose
Secondary	AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
Secondary	Insulin Clearance
Secondary	NNC 90-1 170 plasma concentration
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk