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

Purpose

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).

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: NNC 90-1170 Drug: metformin Drug: placebo Drug: glimepiride	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Fasting plasma/serum glucose [ Designated as safety issue: No ]

Secondary Outcome Measures:

Home monitored fasting plasma glucose [ Designated as safety issue: No ]
Home monitored 7-point glucose profile [ Designated as safety issue: No ]
Fructosamine [ Designated as safety issue: No ]
Insulin [ Designated as safety issue: No ]
C-peptide [ Designated as safety issue: No ]
HbA1c (glycated haemoglobin A1c) [ Designated as safety issue: No ]
Weight [ Designated as safety issue: No ]
Beta-cell function and insulin resistance (HOMA model) [ Designated as safety issue: No ]
Gastro-intestinal adverse events [ Designated as safety issue: No ]
Other adverse events [ Designated as safety issue: No ]

Enrollment:	145
Study Start Date:	August 2002
Study Completion Date:	December 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NNC 90-1170 + Met	Drug: NNC 90-1170 Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously Drug: metformin 1000 mg daily, administered orally
Experimental: NNC 90-1170 + Met placebo	Drug: placebo Metformin placebo administered orally. 1000 mg daily
Placebo Comparator: Met + NNC 90-1170 placebo	Drug: metformin 1000 mg daily, administered orally Drug: placebo NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
Active Comparator: Met + Glim	Drug: metformin 1000 mg daily, administered orally Drug: glimepiride Individually adjusted dose, administered orally

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511172

Locations

Australia

Adelaide, Australia, SA 5035
Austria

Wien, Austria, 1030
Czech Republic

Praha 10, Czech Republic, 10034
Denmark

Frederiksberg, Denmark, 2000
France

Narbonne, France, 11108
Germany

Kaiserslautern, Germany, 67675
Poland

Rawa Mazowiecka, Poland, 96-200
United Kingdom

Bexhill-on-Sea, United Kingdom, TN39 4SP

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Milan Zdravkovic, MD, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01511172 History of Changes
Other Study ID Numbers:	NN2211-1499
Study First Received:	January 12, 2012
Last Updated:	January 17, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Ministry for Health and Women Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Poland: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013