NCT01511198|CompletedPhase 2

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN2211-2072

Study Type

interventional

Target

223

Locations

1 country

Sites

Timeline

RegisteredJan 2012

StartedFeb 2001

CompletionOct 2001

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

223

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Feb 2001

Shorter than P25 for phase_2 diabetes

Geographic Reach

1 country

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

February 1, 2001

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed

10.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed

Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 12, 2012

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Body weight

Secondary Outcomes (5)

FPG (fasting plasma glucose)
HbA1c (glycosylated haemoglobin)
Fructosamine
Lipids
Adverse events

Study Arms (6)

0.045 mg

EXPERIMENTAL

Drug: liraglutide

0.225 mg

EXPERIMENTAL

Drug: liraglutide

0.45 mg

EXPERIMENTAL

Drug: liraglutide

0.60 mg

EXPERIMENTAL

Drug: liraglutide

0.75 mg

EXPERIMENTAL

Drug: liraglutide

Met

ACTIVE COMPARATOR

Drug: metformin

Interventions

liraglutideDRUG

Injected subcutaneously once daily

Also known as: NNC 90-1170

0.045 mg0.225 mg0.45 mg0.60 mg0.75 mg

metforminDRUG

1000 mg twice daily, administered orally

Met

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.