Clinical trial NCT01511198: Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).


Eligibility 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

Primary outcomes:
measure: Body weight
Secondary outcomes:
measure: FPG (fasting plasma glucose)
measure: HbA1c (glycosylated haemoglobin)
measure: Fructosamine
measure: Lipids
measure: Adverse events
Other outcomes:
Locations:
city: Vestavia
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Carlisle
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Alhambra
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Trumbull
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Titusville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Duluth
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: North Plainfield
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Edmonds
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Edmonds
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O; Liraglutide Dose-Response Study Group. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet Med. 2005 Aug;22(8):1016-23. doi: 10.1111/j.1464-5491.2005.01567.x.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.