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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: metformin; Drug: liraglutide; Drug: glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511172

NN2211-1499

Details and patient eligibility

About

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).

Enrollment: 145 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 4 patient groups, including a placebo group

NNC 90-1170 + Met

Experimental group

Treatment:

Drug: liraglutide

Drug: metformin

NNC 90-1170 + Met placebo

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Met + NNC 90-1170 placebo

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: metformin

Met + Glim

Active Comparator group

Treatment:

Drug: glimepiride

Drug: metformin