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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT01511172