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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01509755

NN2211-1310

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

196 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

0.045 mg

Experimental group

Treatment:

Drug: liraglutide

0.225 mg

Experimental group

Treatment:

Drug: liraglutide

0.45 mg

Experimental group

Treatment:

Drug: liraglutide

0.60 mg

Experimental group

Treatment:

Drug: liraglutide

0.75 mg

Experimental group

Treatment:

Drug: liraglutide

Glim

Active Comparator group

Treatment:

Drug: glimepiride

Drug: placebo