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NCT01511172 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01511172
Other study ID # NN2211-1499
Secondary ID
Status Completed
Phase Phase 2
First received January 12, 2012
Last updated January 24, 2017
Start date August 2002
Est. completion date December 2002

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
• metformin
1000 mg daily, administered orally
• placebo
Metformin placebo administered orally. 1000 mg daily
• placebo
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
• glimepiride
Individually adjusted dose, administered orally

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Adelaide
Australia Novo Nordisk Investigational Site Ashford
Australia Novo Nordisk Investigational Site Daw Park South Australia
Australia Novo Nordisk Investigational Site Garran
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Czech Republic Novo Nordisk Investigational Site Ceske Budejovice
Czech Republic Novo Nordisk Investigational Site Praha 10
Denmark Novo Nordisk Investigational Site Århus C
Denmark Novo Nordisk Investigational Site Frederiksberg
Denmark Novo Nordisk Investigational Site København
Denmark Novo Nordisk Investigational Site Køge
Denmark Novo Nordisk Investigational Site Thisted
France Novo Nordisk Investigational Site LA ROCHELLE cedex
France Novo Nordisk Investigational Site Narbonne
France Novo Nordisk Investigational Site NEVERS cedex
France Novo Nordisk Investigational Site Paris Cedex 10
Germany Novo Nordisk Investigational Site Bad Lauterberg
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Bochum
Germany Novo Nordisk Investigational Site Freiburg
Germany Novo Nordisk Investigational Site Kaiserslautern
Germany Novo Nordisk Investigational Site Mannheim
Germany Novo Nordisk Investigational Site Neuss
Poland Novo Nordisk Investigational Site Rawa Mazowiecka
Poland Novo Nordisk Investigational Site Zabrze
United Kingdom Novo Nordisk Investigational Site Addlestone
United Kingdom Novo Nordisk Investigational Site Aylesbury
United Kingdom Novo Nordisk Investigational Site Barnsley
United Kingdom Novo Nordisk Investigational Site Bexhill-on-Sea
United Kingdom Novo Nordisk Investigational Site Caerleon
United Kingdom Novo Nordisk Investigational Site Camberley
United Kingdom Novo Nordisk Investigational Site Chippenham
United Kingdom Novo Nordisk Investigational Site East Horsley
United Kingdom Novo Nordisk Investigational Site Frome
United Kingdom Novo Nordisk Investigational Site Magherafelt
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Soham
United Kingdom Novo Nordisk Investigational Site Sunbury on Thames
United Kingdom Novo Nordisk Investigational Site Yaxley. Peterborough

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Austria,  Czech Republic,  Denmark,  France,  Germany,  Poland,  United Kingdom, 

References & Publications (2)

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- — View 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 Endocri — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Fasting plasma/serum glucose
Secondary Home monitored fasting plasma glucose
Secondary Home monitored 7-point glucose profile
Secondary Fructosamine
Secondary Insulin
Secondary C-peptide
Secondary HbA1c (glycated haemoglobin A1c)
Secondary Weight
Secondary Beta-cell function and insulin resistance (HOMA model)
Secondary Gastro-intestinal adverse events
Secondary Other adverse events
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