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 | RxWiki

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

Overview[ - collapse ][ - ]

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	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: NNC 90-1170 Drug: metformin Drug: placebo Drug: placebo Drug: glimepiride
Phase	Phase 2
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT01511172
First Received	January 12, 2012
Last Updated	April 24, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	January 12, 2012
Last Updated Date	April 24, 2014
Start Date	August 2002
Estimated Primary Completion Date	December 2002
Current Primary Outcome Measures	Fasting plasma/serum glucose [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

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 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
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
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: NNC 90-1170 Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously Drug: metformin 1000 mg daily, adminstered orally Drug: placebo Metformin placebo adminstered orally. 1000 mg daily Drug: placebo NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously Drug: glimepiride Individually adjusted dose, administered orally
Study Arm (s)	Experimental: NNC 90-1170 + Met Experimental: NNC 90-1170 + Met placebo Placebo Comparator: Met + NNC 90-1170 placebo Active Comparator: Met + Glim

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	145
Estimated Completion Date	December 2002
Estimated Primary Completion Date	December 2002
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Australia, Austria, Czech Republic, Denmark, France, Germany, Poland, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT01511172
Other Study ID Numbers	NN2211-1499
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification Date	April 2014

Locations[ + expand ][ + ]

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