Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511198

Enrollment

223

Registered

2012-01-18

Start date

2001-02-28

Completion date

2001-10-31

Last updated

2017-01-26

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 the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Interventions

DRUGliraglutide

Injected subcutaneously once daily

DRUGmetformin

1000 mg twice daily, administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetic * Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed * Body Mass Index (BMI) between 27.0-42.0 kg/m\^2 (inclusive) * HbA1c maximum 10% based on analysis from central laboratory

Exclusion criteria

* Cardiac problems * Uncontrolled treated/untreated hypertension * Proliferative retinopathy or known autonomic neuropathy * Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed * Known or suspected abuse of alcohol or narcotics * Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness * TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL * Type 1 or other specific causes of diabetes

Design outcomes

Primary

Measure	Time frame
Body weight	—

Secondary

Measure	Time frame
FPG (fasting plasma glucose)	—
HbA1c (glycosylated haemoglobin)	—
Fructosamine	—
Lipids	—
Adverse events	—

Countries

United States

Outcome results

None listed

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