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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01511172




Registration number
NCT01511172
Ethics application status
Date submitted
12/01/2012
Date registered
18/01/2012
Date last updated
25/01/2017

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
NN2211-1499
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - metformin
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - glimepiride

Experimental: NNC 90-1170 + Met -

Experimental: NNC 90-1170 + Met placebo -

Placebo comparator: Met + NNC 90-1170 placebo -

Active comparator: Met + Glim -


Treatment: Drugs: liraglutide
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously

Treatment: Drugs: metformin
1000 mg daily, administered orally

Treatment: Drugs: placebo
Metformin placebo administered orally. 1000 mg daily

Treatment: Drugs: placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously

Treatment: Drugs: glimepiride
Individually adjusted dose, administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting plasma/serum glucose
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Home monitored fasting plasma glucose
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Home monitored 7-point glucose profile
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Fructosamine
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Insulin
Timepoint [4] 0 0
Secondary outcome [5] 0 0
C-peptide
Timepoint [5] 0 0
Secondary outcome [6] 0 0
HbA1c (glycated haemoglobin A1c)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Weight
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Beta-cell function and insulin resistance (HOMA model)
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Gastro-intestinal adverse events
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Other adverse events
Timepoint [10] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2002
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Daw Park
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ashford
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment postcode(s) [1] 0 0
5041 - Daw Park
Recruitment postcode(s) [2] 0 0
SA 5035 - Adelaide
Recruitment postcode(s) [3] 0 0
5035 - Ashford
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Ceske Budejovice
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Praha 10
Country [4] 0 0
Denmark
State/province [4] 0 0
Frederiksberg
Country [5] 0 0
Denmark
State/province [5] 0 0
København
Country [6] 0 0
Denmark
State/province [6] 0 0
Køge
Country [7] 0 0
Denmark
State/province [7] 0 0
Thisted
Country [8] 0 0
Denmark
State/province [8] 0 0
Århus C
Country [9] 0 0
France
State/province [9] 0 0
LA ROCHELLE cedex
Country [10] 0 0
France
State/province [10] 0 0
Narbonne
Country [11] 0 0
France
State/province [11] 0 0
NEVERS cedex
Country [12] 0 0
France
State/province [12] 0 0
Paris Cedex 10
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Lauterberg
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Bochum
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Kaiserslautern
Country [18] 0 0
Germany
State/province [18] 0 0
Mannheim
Country [19] 0 0
Germany
State/province [19] 0 0
Neuss
Country [20] 0 0
Poland
State/province [20] 0 0
Rawa Mazowiecka
Country [21] 0 0
Poland
State/province [21] 0 0
Zabrze
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Addlestone
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Aylesbury
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Barnsley
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Bexhill-on-Sea
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Caerleon
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Camberley
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Chippenham
Country [29] 0 0
United Kingdom
State/province [29] 0 0
East Horsley
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Frome
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Magherafelt
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Sheffield
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Soham
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Sunbury on Thames
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Yaxley. Peterborough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01511172
Trial related presentations / publications
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.
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. Erratum In: Diabetes Care. 2015 Aug;38(8):1622. doi: 10.2337/dc15-er08.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01511172