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

NCT ID: NCT01509755

Last Updated: 2017-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2001-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

0.045 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

0.225 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

0.45 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

0.60 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

0.75 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

Glim

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

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

glimepiride

Intervention Type DRUG

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

Interventions

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placebo

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

Intervention Type DRUG

liraglutide

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

Intervention Type DRUG

glimepiride

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

Intervention Type DRUG

Other Intervention Names

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NNC 90-1170

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452), MD

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Århus C, , Denmark

Site Status

Novo Nordisk Investigational Site

Copenhagen, , Denmark

Site Status

Novo Nordisk Investigational Site

Hvidovre, , Denmark

Site Status

Novo Nordisk Investigational Site

Kolding, , Denmark

Site Status

Novo Nordisk Investigational Site

Køge, , Denmark

Site Status

Novo Nordisk Investigational Site

Thisted, , Denmark

Site Status

Novo Nordisk Investigational Site

Bekkestua, , Norway

Site Status

Novo Nordisk Investigational Site

Elverum, , Norway

Site Status

Novo Nordisk Investigational Site

Harstad, , Norway

Site Status

Novo Nordisk Investigational Site

Oslo, , Norway

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Grästorp, , Sweden

Site Status

Novo Nordisk Investigational Site

Lund, , Sweden

Site Status

Novo Nordisk Investigational Site

Örebro, , Sweden

Site Status

Novo Nordisk Investigational Site

Uppsala, , Sweden

Site Status

Novo Nordisk Investigational Site

Ayrsh, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Church Village, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Edinburgh, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Enfield, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Hull, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leicester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Liverpool, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Northampton, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Nottingham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Oxford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Plymouth, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Rugby, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Worksop, , United Kingdom

Site Status

Countries

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Denmark Norway Sweden United Kingdom

References

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Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR; NN2211-1310 International Study Group. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care. 2004 Jun;27(6):1335-42. doi: 10.2337/diacare.27.6.1335.

Reference Type RESULT
PMID: 15161785 (View on PubMed)

Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.

Reference Type RESULT
PMID: 25504028 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2211-1310

Identifier Type: -

Identifier Source: org_study_id

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