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

Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511172

Enrollment

145

Registered

2012-01-18

Start date

2002-08-31

Completion date

2002-12-31

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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 subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

Interventions

DRUGliraglutide

Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously

DRUGmetformin

1000 mg daily, administered orally

DRUGplacebo

Metformin placebo administered orally. 1000 mg daily

DRUGglimepiride

Individually adjusted dose, administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Fasting plasma/serum glucose	—

Secondary

Measure	Time frame
Home monitored 7-point glucose profile	—
Fructosamine	—
Insulin	—
C-peptide	—
Home monitored fasting plasma glucose	—
Weight	—
Beta-cell function and insulin resistance (HOMA model)	—
Gastro-intestinal adverse events	—
Other adverse events	—
HbA1c (glycated haemoglobin A1c)	—

Countries

Australia, Austria, Czechia, Denmark, France, Germany, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026