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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

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ClinicalTrials.gov Identifier: NCT01511172
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: metformin Drug: placebo Drug: glimepiride Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2002
Primary Completion Date : December 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: NNC 90-1170 + Met Drug: liraglutide
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

Outcome Measures

Primary Outcome Measures :
  1. Fasting plasma/serum glucose

Secondary Outcome Measures :
  1. Home monitored fasting plasma glucose
  2. Home monitored 7-point glucose profile
  3. Fructosamine
  4. Insulin
  5. C-peptide
  6. HbA1c (glycated haemoglobin A1c)
  7. Weight
  8. Beta-cell function and insulin resistance (HOMA model)
  9. Gastro-intestinal adverse events
  10. Other adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511172

  Show 41 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511172     History of Changes
Other Study ID Numbers: NN2211-1499
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors