Effect of Liraglutide as add-on to Metformin Compared to... | NCT01511172

Studies
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

NCT01511172

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 25, 2017Estimated

Enrollment

145Actual

Phase

Phase 2

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

liraglutide
metformin
placebo
placebo
glimepiride

Countries

Australia
Austria
Czechia
Denmark
France
Germany
Poland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2002Actual

First Submitted Date

Jan 12, 2012

First Submission Date that Met QC Criteria

Jan 17, 2012

First Posted Date

Jan 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2017

Last Update Posted Date

Jan 25, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
NNC 90-1170 + Met	Experimental	Drug: liraglutide Drug: metformin
NNC 90-1170 + Met placebo	Experimental	Drug: placebo
Met + NNC 90-1170 placebo	Placebo Comparator	Drug: metformin Drug: placebo
Met + Glim	Active Comparator	Drug: metformin Drug: glimepiride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously	NNC 90-1170 + Met

Measure	Description	Time Frame
Fasting plasma/serum glucose

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Daw Park	South Australia	5041	Australia
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17039422	Result	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.
25504028	Result

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Measure	Description	Time Frame
Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine