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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511172
First received: January 12, 2012
Last updated: April 24, 2014
Last verified: April 2014
  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:


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: December 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, adminstered orally
Experimental: NNC 90-1170 + Met placebo Drug: placebo
Metformin placebo adminstered orally. 1000 mg daily
Placebo Comparator: Met + NNC 90-1170 placebo Drug: metformin
1000 mg daily, adminstered 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, adminstered 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: 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: April 24, 2014
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 July 29, 2014