Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01511172
Start Date
August 1 2002
End Date
December 1 2002
Last Update
January 25 2017
Active Locations (41)
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1
Novo Nordisk Investigational Site
Daw Park, South Australia, Australia, 5041
2
Novo Nordisk Investigational Site
Adelaide, Australia, SA 5035
3
Novo Nordisk Investigational Site
Ashford, Australia, 5035
4
Novo Nordisk Investigational Site
Garran, Australia, 2605