Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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: January 24, 2017
Last verified: January 2017
  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: liraglutide
Drug: metformin
Drug: placebo
Drug: glimepiride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fasting plasma/serum glucose

Secondary Outcome Measures:
  • Home monitored fasting plasma glucose
  • Home monitored 7-point glucose profile
  • Fructosamine
  • Insulin
  • C-peptide
  • HbA1c (glycated haemoglobin A1c)
  • Weight
  • Beta-cell function and insulin resistance (HOMA model)
  • Gastro-intestinal adverse events
  • Other adverse events

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: 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

  Eligibility

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

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

Additional Information:
Publications:
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: January 24, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017