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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511185

Enrollment

Registered

2012-01-18

Start date

2001-02-28

Completion date

2001-10-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGliraglutide

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

DRUGplacebo

A single dose administered subcutaneously in random order

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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%

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026