Status:
COMPLETED
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 (liraglutid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2001
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01511198
Start Date
February 1 2001
End Date
October 1 2001
Last Update
January 26 2017
Active Locations (39)
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1
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States, 35209
2
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85719
3
Novo Nordisk Investigational Site
Carlisle, Arkansas, United States, 72024
4
Novo Nordisk Investigational Site
Jonesboro, Arkansas, United States, 72401