Overview

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

Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Glimepiride
Liraglutide
Metformin
Criteria
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