Completed

Dose-response of NNC 90-1170 and Metformin in Previously-treated Obese Type 2 Diabetes Patients

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Study Aim

This study aims to evaluate the optimal dose and response of NNC 90-1170 combined with Metformin in previously-treated obese patients with Type 2 Diabetes, primarily focusing on changes in body weight.

What is being tested

liraglutide

+ metformin

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2001
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2001

Actual date on which the first participant was enrolled.

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).

Official TitleNNC 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
NCT01511198
Principal SponsorNovo Nordisk A/S
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

223 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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
10 exclusion criteria prevent from participating
Cardiac problems
Uncontrolled treated/untreated hypertension
Proliferative retinopathy or known autonomic neuropathy
Recurrent severe hypoglycemia as judged by the investigator
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Group 6

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 39 locations

Suspended

Novo Nordisk Investigational Site

Vestavia Hills, United StatesOpen Novo Nordisk Investigational Site in Google Maps
Suspended

Novo Nordisk Investigational Site

Tucson, United States
Suspended

Novo Nordisk Investigational Site

Carlisle, United States
Suspended

Novo Nordisk Investigational Site

Jonesboro, United States
Completed39 Study Centers