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