Clinical trial NCT01508923: Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes
Official title: Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
* Body Mass Index (BMI) maximum 35 kg/m\^2
* Fasting plasma glucose 7-15 mmol/l, both inclusive

Exclusion Criteria:

* Impaired liver function
* Impaired renal function
* Anaemia
* Cardiac disease
* Uncontrolled treated/untreated hypertension
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
* Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
* Loss of more than 400 ml blood during the three months prior to study start
* Allergy to paracetamol

Primary outcomes:
measure: 24-hour glucose profiles after three fixed meals
Secondary outcomes:
measure: 24-hour insulin profiles after three fixed meals
measure: First phase insulin and maximal insulin secretory capacity
measure: EGR (endogenous glucose release) expressed in mg/kg/min
measure: GNG (gluconeogenesis) expressed in mg/kg/min
measure: 24-hour glucagon profiles after three fixed meals
measure: 24-hour FFA (free fatty acids) profiles after three fixed meals
measure: 4-hour paracetamol profiles after two fixed meals
measure: 30-hour NNC 90-1170 profile
measure: Adverse events
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Degn KB, Juhl CB, Sturis J, Jakobsen G, Brock B, Chandramouli V, Rungby J, Landau BR, Schmitz O. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004 May;53(5):1187-94. doi: 10.2337/diabetes.53.5.1187.