Clinical trial NCT01511172: Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
Official title: Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm
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: 2012-01-18
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
* Duration of type 2 diabetes diagnosis at least one year
* HbA1c 8.0-13.0%, both inclusive
* Body Mass Index (BMI) between 25-40 kg/m\^2, both inclusive.

Exclusion Criteria:

* Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level
* Known or suspected abuse of alcohol or narcotics
* Any contraindications to metformin or glimepiride according to the local guidelines

Primary outcomes:
measure: Fasting plasma/serum glucose
Secondary outcomes:
measure: Home monitored fasting plasma glucose
measure: Home monitored 7-point glucose profile
measure: Fructosamine
measure: Insulin
measure: C-peptide
measure: HbA1c (glycated haemoglobin A1c)
measure: Weight
measure: Beta-cell function and insulin resistance (HOMA model)
measure: Gastro-intestinal adverse events
measure: Other adverse events
Other outcomes:
Locations:
city: Daw Park
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: Adelaide
country: Australia
facility: Novo Nordisk Investigational Site
city: Ashford
country: Australia
facility: Novo Nordisk Investigational Site
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 10
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Frederiksberg
country: Denmark
facility: Novo Nordisk Investigational Site
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Thisted
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: Paris Cedex 10
country: France
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bochum
country: Germany
facility: Novo Nordisk Investigational Site
city: Freiburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Kaiserslautern
country: Germany
facility: Novo Nordisk Investigational Site
city: Mannheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
city: Rawa Mazowiecka
country: Poland
facility: Novo Nordisk Investigational Site
city: Zabrze
country: Poland
facility: Novo Nordisk Investigational Site
city: Addlestone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Aylesbury
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Barnsley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Caerleon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Camberley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Chippenham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: East Horsley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Frome
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Magherafelt
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Soham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sunbury on Thames
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Yaxley. Peterborough
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.