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NCT01509755 Clinical Trial

Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01509755
Other study ID # NN2211-1310
Secondary ID
Status Completed
Phase Phase 2
First received January 6, 2012
Last updated January 23, 2017
Start date October 2000
Est. completion date October 2001

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. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.

Recruitment information / eligibility
Status Completed
Enrollment 196
Est. completion date October 2001
Est. primary completion date October 2001
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- Subjects with type 2 diabetes

- Duration of diabetes at least 3 months

- Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)

- Body Mass Index maximum 40 kg/m^2

- HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated

Exclusion Criteria:

- Liver or renal disease

- Cardiac problems

- Uncontrolled treated/untreated hypertension

- Proliferative retinopathy

- Recurrent severe 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 blood glucose level

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• placebo
Once daily injection, under the skin (s.c.) for 12 weeks
• liraglutide
Once daily injection, under the skin (s.c.) for 12 weeks
• glimepiride
Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Århus C
Denmark Novo Nordisk Investigational Site Hvidovre
Denmark Novo Nordisk Investigational Site København
Denmark Novo Nordisk Investigational Site Køge
Denmark Novo Nordisk Investigational Site Kolding
Denmark Novo Nordisk Investigational Site Thisted
Norway Novo Nordisk Investigational Site Bekkestua
Norway Novo Nordisk Investigational Site Elverum
Norway Novo Nordisk Investigational Site Harstad
Norway Novo Nordisk Investigational Site Oslo
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Grästorp
Sweden Novo Nordisk Investigational Site Lund
Sweden Novo Nordisk Investigational Site Örebro
Sweden Novo Nordisk Investigational Site Uppsala
United Kingdom Novo Nordisk Investigational Site Ayrsh
United Kingdom Novo Nordisk Investigational Site Church Village
United Kingdom Novo Nordisk Investigational Site Edinburgh
United Kingdom Novo Nordisk Investigational Site Enfield
United Kingdom Novo Nordisk Investigational Site Hull
United Kingdom Novo Nordisk Investigational Site Leicester
United Kingdom Novo Nordisk Investigational Site Liverpool
United Kingdom Novo Nordisk Investigational Site Northampton
United Kingdom Novo Nordisk Investigational Site Nottingham
United Kingdom Novo Nordisk Investigational Site Oxford
United Kingdom Novo Nordisk Investigational Site Plymouth
United Kingdom Novo Nordisk Investigational Site Rugby
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Worksop

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

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden,  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

Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR; NN2211-1310 International Study Group.. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 an — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin)
Secondary Fasting plasma glucose
Secondary Fructosamine
Secondary 7-point blood glucose profile
Secondary Adverse events
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