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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511198
First received: January 12, 2012
Last updated: January 23, 2012
Last verified: January 2012
  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: NNC 90-1170
Drug: metformin
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: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG (fasting plasma glucose) [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Fructosamine [ Designated as safety issue: No ]
  • Lipids [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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: NNC 90-1170
Injected subcutaneously once daily
Experimental: 0.225 mg Drug: NNC 90-1170
Injected subcutaneously once daily
Experimental: 0.45 mg Drug: NNC 90-1170
Injected subcutaneously once daily
Experimental: 0.60 mg Drug: NNC 90-1170
Injected subcutaneously once daily
Experimental: 0.75 mg Drug: NNC 90-1170
Injected subcutaneously once daily
Active Comparator: Met Drug: metformin
1000 mg twice daily, administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01511198

  Show 36 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Nielsen, DDS Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01511198     History of Changes
Other Study ID Numbers: NN2211-2072
Study First Received: January 12, 2012
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014