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Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511198
First Posted: January 18, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: metformin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Body weight

Secondary Outcome Measures:
  • FPG (fasting plasma glucose)
  • HbA1c (glycosylated haemoglobin)
  • Fructosamine
  • Lipids
  • Adverse events

Enrollment: 223
Study Start Date: February 2001
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.045 mg Drug: liraglutide
Injected subcutaneously once daily
Other Name: NNC 90-1170
Experimental: 0.225 mg Drug: liraglutide
Injected subcutaneously once daily
Other Name: NNC 90-1170
Experimental: 0.45 mg Drug: liraglutide
Injected subcutaneously once daily
Other Name: NNC 90-1170
Experimental: 0.60 mg Drug: liraglutide
Injected subcutaneously once daily
Other Name: NNC 90-1170
Experimental: 0.75 mg Drug: liraglutide
Injected subcutaneously once daily
Other Name: NNC 90-1170
Active Comparator: Met Drug: metformin
1000 mg twice daily, administered orally

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic
  • Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
  • Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
  • HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Proliferative retinopathy or known autonomic neuropathy
  • Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
  • Known or suspected abuse of alcohol or narcotics
  • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
  • TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
  • Type 1 or other specific causes of diabetes
  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): NCT01511198


  Show 39 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: NCT01511198     History of Changes
Other Study ID Numbers: NN2211-2072
First Submitted: January 12, 2012
First Posted: January 18, 2012
Last Update Posted: January 26, 2017
Last Verified: January 2017

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