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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

placebo

liraglutide

glimepiride

About this trial

This is an interventional trial for Diabetes

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

0.045 mg

0.225 mg

0.45 mg

0.60 mg

0.75 mg

Glim

Arm Description

Outcomes

Primary Outcome Measures

HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Fasting plasma glucose

Fructosamine

7-point blood glucose profile

Adverse events

Full Information

NCT ID

NCT01509755

First Posted

January 6, 2012

Last Updated

January 23, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01509755

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

October 2001 (Actual)

Study Completion Date

October 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Study Phase

Phase 2

Enrollment

196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

0.045 mg

Arm Type

Experimental

Arm Title

0.225 mg

Arm Type

Experimental

Arm Title

0.45 mg

Arm Type

Experimental

Arm Title

0.60 mg

Arm Type

Experimental

Arm Title

0.75 mg

Arm Type

Experimental

Arm Title

Glim

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

liraglutide

Other Intervention Name(s)

NNC 90-1170

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

glimepiride

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c (glycosylated haemoglobin)

Secondary Outcome Measure Information:

Title

Fasting plasma glucose

Title

Fructosamine

Title

7-point blood glucose profile

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452), MD

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Kolding

ZIP/Postal Code

6000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

København

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Køge

ZIP/Postal Code

4600

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Thisted

ZIP/Postal Code

7700

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Århus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Bekkestua

ZIP/Postal Code

1357

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Elverum

ZIP/Postal Code

2408

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Harstad

ZIP/Postal Code

9480

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0370

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Grästorp

ZIP/Postal Code

467 22

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Ayrsh

ZIP/Postal Code

KA2 0BE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Church Village

ZIP/Postal Code

CF38 1AB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Enfield

ZIP/Postal Code

EN2 8JL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Northampton

ZIP/Postal Code

NN1 5BD

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Oxford

ZIP/Postal Code

OX2 6HE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Plymouth

ZIP/Postal Code

PL8 8DQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rugby

ZIP/Postal Code

CV22 5PX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Worksop

ZIP/Postal Code

S81 OBD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

15161785

Citation

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.

Results Reference

result

PubMed Identifier

25504028

Citation

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. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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

Diabetes, Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial