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Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
liraglutide
metformin
placebo
placebo
glimepiride
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
  • Duration of type 2 diabetes diagnosis at least one year
  • HbA1c 8.0-13.0%, both inclusive
  • Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.

Exclusion Criteria:

  • Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
  • Impaired liver function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
  • Recurrent major 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 glucose level
  • Known or suspected abuse of alcohol or narcotics
  • Any contraindications to metformin or glimepiride according to the local guidelines

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

NNC 90-1170 + Met

NNC 90-1170 + Met placebo

Met + NNC 90-1170 placebo

Met + Glim

Arm Description

Outcomes

Primary Outcome Measures

Fasting plasma/serum glucose

Secondary Outcome Measures

Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine
Insulin
C-peptide
HbA1c (glycated haemoglobin A1c)
Weight
Beta-cell function and insulin resistance (HOMA model)
Gastro-intestinal adverse events
Other adverse events

Full Information

First Posted
January 12, 2012
Last Updated
January 24, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01511172
Brief Title
Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
Official Title
Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

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

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC 90-1170 + Met
Arm Type
Experimental
Arm Title
NNC 90-1170 + Met placebo
Arm Type
Experimental
Arm Title
Met + NNC 90-1170 placebo
Arm Type
Placebo Comparator
Arm Title
Met + Glim
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
1000 mg daily, administered orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Metformin placebo administered orally. 1000 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
Individually adjusted dose, administered orally
Primary Outcome Measure Information:
Title
Fasting plasma/serum glucose
Secondary Outcome Measure Information:
Title
Home monitored fasting plasma glucose
Title
Home monitored 7-point glucose profile
Title
Fructosamine
Title
Insulin
Title
C-peptide
Title
HbA1c (glycated haemoglobin A1c)
Title
Weight
Title
Beta-cell function and insulin resistance (HOMA model)
Title
Gastro-intestinal adverse events
Title
Other adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months Duration of type 2 diabetes diagnosis at least one year HbA1c 8.0-13.0%, both inclusive Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive. Exclusion Criteria: Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial Impaired liver function Impaired renal function Cardiac problems Uncontrolled treated/untreated hypertension Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial Recurrent major 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 glucose level Known or suspected abuse of alcohol or narcotics Any contraindications to metformin or glimepiride according to the local guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Adelaide
ZIP/Postal Code
SA 5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ashford
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
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
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NEVERS cedex
ZIP/Postal Code
58033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kaiserslautern
ZIP/Postal Code
67675
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rawa Mazowiecka
ZIP/Postal Code
96-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Addlestone
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Aylesbury
ZIP/Postal Code
HP21 7TL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Barnsley
ZIP/Postal Code
S70 3RJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bexhill-on-Sea
ZIP/Postal Code
TN39 4SP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Caerleon
ZIP/Postal Code
NP18 1AZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Camberley
ZIP/Postal Code
GU15 2NN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Chippenham
ZIP/Postal Code
SN15 1HP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
East Horsley
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Frome
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Magherafelt
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S3 9DA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Soham
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sunbury on Thames
ZIP/Postal Code
TW16 6RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Yaxley. Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17039422
Citation
Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
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

Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

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