NCT01509755|CompletedPhase 2

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

Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN2211-1310

Study Type

interventional

Target

196

Locations

4 countries

Sites

Timeline

RegisteredJan 2012

StartedOct 2000

CompletionOct 2001

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

196

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Oct 2000

Shorter than P25 for phase_2 diabetes

Geographic Reach

4 countries

29 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

October 1, 2000

Completed

1 year 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 6, 2012

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed

Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 6, 2012

Last Update Submit

January 23, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

Fasting plasma glucose
Fructosamine
7-point blood glucose profile
Adverse events

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Drug: placebo

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

Glim

ACTIVE COMPARATOR

Drug: placeboDrug: glimepiride

Interventions

placeboDRUG

Once daily injection, under the skin (s.c.) for 12 weeks

GlimPlacebo

liraglutideDRUG

Once daily injection, under the skin (s.c.) for 12 weeks

Also known as: NNC 90-1170

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

glimepirideDRUG

Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response

Glim

Eligibility Criteria

Age30 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.