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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01511185
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC 90-1170	placebo	-
Placebo	liraglutide	-
NNC 90-1170	liraglutide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
Insulin Clearance
Slope of the mean ISR vs mean glucose
NNC 90-1 170 plasma concentration
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Ann Arbor, Michigan, United States