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Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01507311
Enrollment
11
Registered
2012-01-10
Start date
1999-09-30
Completion date
1999-12-31
Last updated
2017-01-24

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 Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

Interventions

DRUGliraglutide

A single dose injected subcutaneously (under the skin)

DRUGplacebo

A single dose injected subcutaneously (under the skin)

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months * BMI (Body Mass Index) between 24 and 35 kg/m\^2 (both inclusive) * Fasting plasma glucose between 6 and 15 mmol/l (both inclusive) * Anti-GAD (glutamic acid decarboxylase) negative

Exclusion criteria

* Known or suspected allergy to trial product or related products * Receipt of any investigational drug within three months prior to this trial * Recurrent severe hypoglycaemia as judged by the investigator * Cardiac disease or any clinically significant abnormal ECG (electrocardiogram) * Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere * with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides) * Liver or renal disease

Design outcomes

Primary

MeasureTime frame
Insulin secretory burst mass

Secondary

MeasureTime frame
Insulin secretory pulse mass, amplitude, frequency and regularity
Insulin secretion
Glucagon response
Gastric emptying rate
Adverse events

Countries

Denmark

Outcome results

None listed

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