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

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012

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 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:

Further study details as provided by Novo Nordisk A/S:

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


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

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

Adelaide, Australia, SA 5035
Wien, Austria, 1030
Czech Republic
Praha 10, Czech Republic, 10034
Frederiksberg, Denmark, 2000
Narbonne, France, 11108
Kaiserslautern, Germany, 67675
Rawa Mazowiecka, Poland, 96-200
United Kingdom
Bexhill-on-Sea, United Kingdom, TN39 4SP
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
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
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 April 17, 2014